CLODERM® CREAM Not a cookie-cutter topical

®
CLODERM CREAM
Not a cookie-cutter topical steroid
Different by Design
• Unique molecular structure provides midstrength efficacy with
an excellent safety profile1-3
• Only Cloderm Cream offers the versatility of both a tube and pump
To request samples or for further information,
contact Promius Pharma at 888.384.6929
Indication and Important Safety Information
Cloderm Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The
most common adverse events with Cloderm Cream include burning, itching, irritation, dryness, and folliculitis. Cloderm Cream is
contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic
absorption can produce reversible HPA-axis suppression. See full prescribing information on reverse side. For more information
see www.Cloderm.com.
References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of halogen in corticosteroids influences potency and side effects. J Drug Dermatol. 2006;5(2):125-130. 2. Del
Rosso J, Friedlander S. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005;53(1 Suppl 1):S50-58. 3. Data on file. Promius Pharma, LLC: Bridgewater, NJ.
Cloderm® is a trademark of Coria Laboratories, Ltd.
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dt0112_cvtp1r1.pgs 12.27.2011 10:19
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RxOnly
FOR TOPICAL DERMATOLOGIC USE ONLY–
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
WARNING: KEEP OUT OF REACH OF CHILDREN
DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical
corticosteroid, clocortolone pivalate, in a specially formulated water-washable
emollient cream base consisting of purified water, white petrolatum, mineral
oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium,
sodium hydroxide, with methylparaben and propylparaben as preservatives.
Chemically, clocortolone pivalate is
9-chloro-6α-fluoro-11β,
21-dihydroxy-16α methylpregna-1,
4-diene-3, 20-dione 21-pivalate.
Its structure is as follows:
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids
is unclear. Various laboratory methods, including vasoconstrictor assays,
are used to compare and predict potencies and/or clinical efficacies of the
topical corticosteroids. There is some evidence to suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic efficacy
in man.
Pharmacokinetics: The extent of percutaneous absorption of topical
corticosteroids is determined by many factors including the vehicle, the
integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation
and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption
of topical corticosteroids. Thus, occlusive dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses.
(See DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways similar to systemically administered
corticosteroids. Corticosteroids are bound to plasma proteins in varying
degrees. Corticosteroids are metabolized primarily in the liver and are
then excreted by the kidneys. Some of the topical corticosteroids and their
metabolites are also excreted into the bile.
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief
of the inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those
patients with a history of hypersensitivity to any of the components of the
preparation.
PRECAUTIONS: General: Systemic absorption of topical corticosteroids has
produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression,
manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in
some patients.
Conditions which augment systemic absorption include the application of the
more potent steroids, use over large surface areas, prolonged use, and the
addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied
to a large surface area or under an occlusive dressing should be evaluated
periodically for evidence of HPA axis suppression by using the urinary free
cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an
attempt should be made to withdraw the drug, to reduce the frequency of
application, or to substitute a less potent steroid.
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Recovery of HPA axis function is generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid
withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity.
(See PRECAUTIONS-Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and
appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate
antifungal or antibacterial agent should be instituted. If a favorable response
does not occur promptly, the corticosteroid should be discontinued until the
infection has been adequately controlled.
Information for the Patient: Patients using topical corticosteroids should
receive the following information and instructions:
1. This medication is to be used as directed by the physician. It is for
external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder
other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or
wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially
under occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting
diapers or plastic pants on a child being treated in the diaper area, as
these garments may constitute occlusive dressings.
Laboratory Tests: The following tests may be helpful in evaluating the HPA
axis suppression:
Urinary free cortisol test
ACTH stimulation test
ADVERSE REACTIONS:
The following local adverse reactions are reported infrequently with topical
corticosteroids, but may occur more frequently with the use of occlusive
dressings. These reactions are listed in an approximate decreasing order of
occurrence:
Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform
eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis,
Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria
OVERDOSAGE:
Topically applied corticosteroids can be absorbed in sufficient amounts to
produce systemic effects (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION:
Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the
affected areas three times a day and rub in gently.
Occlusive dressings may be used for the management of psoriasis or
recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be
discontinued and appropriate anti-microbial therapy instituted.
HOW SUPPLIED:
Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75
gram pump bottles, 45 gram and 90 gram tubes.
Store Cloderm Cream between 15° and 30° C (59° and 86° F).
Avoid freezing.
Distributed by:
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal
studies have not been performed to evaluate the carcinogenic potential or the
effect on fertility of topical corticosteroids.
www.promiuspharma.com
Studies to determine mutagenicity with prednisolone and hydrocortisone
have revealed negative results.
Promius Pharma, LLC
200 Somerset Corporate Blvd., Bridgewater, NJ 08807
Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory
animals when administered systemically at relatively low dosage levels. The
more potent corticosteroids have been shown to be teratogenic after dermal
application in laboratory animals. There are no adequate and well-controlled
studies in pregnant women on teratogenic effects from topically applied
corticosteroids. Therefore, topical corticosteroids should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively on pregnant patients, in
large amounts, or for prolonged periods of time.
Manufactured by:
DPT LABORATORIES, LTD.
San Antonio, Texas 78215
Nursing Mothers: It is not known whether topical administration
of corticosteroids could result in sufficient systemic absorption to
produce detectable quantities in breast milk. Systemically administered
corticosteroids are secreted into breast milk in quantities not likely to have
deleterious effect on the infant. Nevertheless, caution should be exercised
when topical corticosteroids are administered to a nursing woman.
Cloderm® is a trademark of Coria Laboratories, Ltd.
Reorder No.13548-031-30 (30g) pump bottle
Reorder No.13548-031-45 (45g) tube
Reorder No.13548-031-75 (75g) pump bottle
Reorder No.13548-031-90 (90g) tube
Rev.Date June 2011
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to
topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome
than mature patients because of a larger skin surface area body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome,
and intracranial hypertension have been reported in children receiving
topical corticosteroids. Manifestations of adrenal suppression in children
include linear growth retardation, delayed weight gain, low plasma cortisol
levels, and absence of response to ACTH stimulation. Manifestations of
intracranial hypertension include bulging fontanelles, headaches, and
bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the
least amount compatible with an effective therapeutic regimen. Chronic
corticosteroid therapy may interfere with the growth and development of
children.
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January 2012
Vol. 33, No. 1
®
DermatologyTimes.com
Leading News and Analysis for Today’s Dermatologists
‘Chronic’ shortage
of derms leaves some areas
underserved
EDITOR’S NOTE: It’s a continuing problem: Patient requests exceed the time
slots available at dermatologists’ offices across the country. Some of the
numbers are slowly changing, but wait times remain lengthy, and solutions are
complicated, say doctors who have studied the metrics.
By Lisette Hilton
Staff Correspondent
National report — Robert Brodell, M.D., has been searching for an
associate for three years — to no avail. The northeast Ohio dermatologist says he works about 50 hours a week, but still has more patients
than he can comfortably handle. People with non-emergencies typically
wait six to eight weeks for an appointment.
Despite his efforts to attractively pitch Warren — a city of about 210,000
that’s fairly close to both Cleveland and Pittsburgh — it’s hard to persuade
inside:
clinical
25 dermatology
cosmetic
42 dermatology
46
cutaneous
oncology
practice
52 management
special
32 report
young dermatologists to sign on in the area, Dr. Brodell says.
“I know that there’s a guy across town from me who would have
retired three years ago, if somebody could have come and taken over his
practice,” he says.
Dr. Brodell’s experience isn’t unique. Dermatologists around the
country are having trouble keeping up with demand, and it doesn’t appear
that’s going to change anytime soon. It’s a patchy problem: Some areas
have too few practitioners; some have better numbers. Still, patient wait
times remain frustratingly long virtually everywhere.
And for younger doctors, it’s a buyer’s market. The job offers remain
abundant, says Kathleen Beckum, M.D., who finished her dermatology
training at the University of Alabama at Birmingham in June 2011.
“There were both private practice and academic opportunities locally
and across the country when I was completing residency,” she says. “It was
Supply & demand: Long wait times continue See page 16
Good morning
Afternoon sun exposure carries greater risk of skin cancer in humans
By Bob Roehr
Staff Correspondent
National report — The risk of developing skin cancer
from sun exposure in the afternoon is significantly
greater than from exposure in the morning, a new
study shows.
What makes the difference? It’s not the exposure, per
se, but the cellular repair mechanism for UV damage
to DNA, which is circadian in nature and at its peak
efficiency early in the day.
The discovery was made in mice — nocturnal
animals whose circadian cycle is the opposite of that in
humans — by Aziz Sancar, M.D., Ph.D., and published
in the journal Proceedings of the National Academy
of Sciences. Dr. Sancar, a professor of biochemistry at
the University of North Carolina School of Medicine,
Chapel Hill, has made many important discoveries
concerning circadian rhythms.
UV radiation causes DNA damage either in the
form of cyclobutane pyrimidine dimer (CPD) or the
(6-4) photoproduct. Both changes are mutagenic and
carcinogenic in the animal model. Mice and humans
share the same, sole molecular mechanism to excise
and repair sun-damaged nucleotides. Part of that
mechanism is xeroderma pigmentosum group A (XPA)
protein, whose deficiency causes the disease for which
Morning: Cancer risk higher in afternoon See page 22
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
Brief Summary
Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1%
or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses
patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres
(MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous
gel.
IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing
information provided with the product and therefore should not be used as the basis
for prescribing the product. This summary has been prepared by deleting information
from the complete prescribing information such as certain text, tables, and references.
The physician should be thoroughly familiar with the complete prescribing information
before prescribing the product.
INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is
indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the
use of this product in the treatment of other disorders have not been established.
CONTRAINDICATIONS: This drug is contraindicated in individuals with a history of sensitivity
reactions to any of its components. It should be discontinued if hypersensitivity to any of its
ingredients is noted.
PRECAUTIONS:
General:
• The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the
degree of irritation warrants, patients should be directed to temporarily reduce the amount
or frequency of application of the medication, discontinue use temporarily, or discontinue
use all together. Efficacy at reduced frequencies of application has not been established.
If a reaction suggesting sensitivity occurs, use of the medication should be discontinued.
Excessive skin dryness may also be experienced; if so, use of an appropriate emollient
during the day may be helpful.
• Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of
Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should
be advised not to use the product until fully recovered because of heightened susceptibility to
sunlight as a result of the use of tretinoin. Patients who may be required to have considerable
sun exposure due to occupation and those with inherent sensitivity to the sun should exercise
particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated
areas are recommended when exposure cannot be avoided.
• Weather extremes, such as wind or cold, also may be irritating to patients under treatment
with tretinoin.
• Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the
eyes, the mouth, paranasal creases of the nose, and mucous membranes.
• Tretinoin has been reported to cause severe irritation on eczematous skin and should be used
with utmost caution in patients with this condition.
Information for Patients: A Patient Information Leaflet has been prepared and is included with
each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%.
Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers,
products that have a strong drying effect, products with high concentrations of alcohol, astringents,
or spices should be used with caution because of possible interaction with tretinoin. Avoid contact
with the peel of limes. Particular caution should be exercised with the concomitant use of topical
over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid
with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the
effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere,
0.1% and 0.04%, is begun.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in
which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in
some female mice. These concentrations are near the tretinoin concentration of these clinical
formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was
observed at those same doses. The maximum systemic doses associated with the administered
0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are
two and four times the maximum human systemic dose applied topically, when normalized
for total body surface area. The biological significance of these findings is not clear because
they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin
and because they were within the background natural occurrence rate for these tumors in
this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day
of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose,
normalized for total body surface area). For purposes of comparisons of the animal exposure
to systemic human exposure, the maximum human systemic dose applied topically is defined
as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person
(0.02 mg tretinoin/kg body weight).
Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel)
microsphere, 0.04% or 0.1%.
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the
tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This
effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not
overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance
of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial
ultraviolet irradiation sources.
The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse
micronucleus assay, both of which were negative.
The components of the microspheres have shown potential for genetic toxicity and teratogenesis.
EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural
chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in
the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the
HGPRT forward mutation assay, and the mouse micronucleus assay.
In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times
the maximum human systemic dose applied topically, and normalized for total body surface
area), and slight (not statistically significant) increases in the number and percent of nonviable
embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose
applied topically and normalized for total body surface area) and above were observed. In oral
Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and
growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human
topical dose normalized for total body surface area).
Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere,
0.1% or 0.04%, have not been performed in any species.
Pregnancy: Teratogenic Effects: Pregnancy Category C.
In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel)
microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8
times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%)
some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant
New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at
doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing
Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences
of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced
fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were
not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after
topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total
body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant
rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin
exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/
kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic
effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical
administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface
area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non
Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits
when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface
area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically).
At these topical doses, however, delayed ossification of several bones occurred in rabbits. In
rats, a dose-dependent increase of supernumerary ribs was observed.
Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses
greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total
body surface area). However, variations in teratogenic doses among various strains of rats have
been reported. In the cynomolgus monkey, which metabolically is more similar to humans than
other species in its handling of tretinoin, fetal malformations were reported for doses of 10
mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human
systemic dose normalized for total body surface area), although increased skeletal variations
were observed at all doses. Dose-related increases in embryolethality and abortion also were
reported. Similar results have also been reported in pigtail macaques.
Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence
for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater
than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface
area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have
also been reported when 10 mg/kg/day was topically applied. Supernumerary ribs have been a
consistent finding in rats when dams were treated topically or orally with retinoids.
There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be
used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
With widespread use of any drug, a small number of birth defect reports associated temporally
with the administration of the drug would be expected by chance alone. Thirty human cases
of temporally associated congenital malformations have been reported during two decades of
clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association
has been established from these cases, five of the reports describe the rare birth defect category
holoprosencephaly (defects associated with incomplete midline development of the forebrain). The
significance of these spontaneous reports in terms of risk to the fetus is not known.
Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when
administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and
normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased
intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human
systemic dose applied topically and normalized for total body surface area).
There are, however no adequate and well-controlled studies in pregnant women.
Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human
systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%,
normalized for total body surface area) for 90 days, a reduction in testicular weight, but with
no pathological changes were observed at the two highest doses. Similarly, in female mice
there was a reduction in ovarian weights, but without any underlying pathological changes, at
5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related
increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to
unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed
is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel)
microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum
human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere,
0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of
reduced testicular or ovarian weights or pathological changes.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, caution should be exercised when Retin-A Micro (tretinoin
gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.
Geriatric Use: Safety and effectiveness in a geriatric population have not been established.
Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and
over to determine whether they respond differently from younger subjects.
ADVERSE REACTIONS:
The skin of certain sensitive individuals may become excessively red, edematous, blistered, or
crusted. If these effects occur, the medication should either be discontinued until the integrity
of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.
However, efficacy has not been established for lower dosing frequencies.
True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been
reported to have heightened susceptibility to sunlight while under treatment with tretinoin.
OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical
use only. If medication is applied excessively, no more rapid or better results will be obtained and
marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug
may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
Rx only.
Distributed by: Ortho Dermatologics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.,
Los Angeles, CA 90045
© OMP 2011
11DD0126 07/11
RETIN-A MICRO ® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.
MICROSPONGE ® is a registered trademark of AMCOL International Corporation.
4
Dermatology Times |
from our board
January 2012
Norman Levine, M.D.,
is a private practitioner in
Tucson, Ariz.
®
JAnuARy 2012
Looking toward
medicine’s future
A peek into tomorrow’s insurance,
medical care paradigms isn’t necessarily pretty
A
few months ago, I
received a certified
letter (never a good
sign) from one of the
Medicare Advantage insurance carriers with which we are contracted.
This is a company that recently
started doing business in our state
and advertised itself as different
from others in that quality patient
care at an affordable price would be
their primary concern. In fact, their
rates were very competitive, and
since their introduction into the marketplace they have done very well at
attracting new customers.
The letter was written by an
account executive and stated
that our services were no longer
needed and that our contract would
not be renewed when it expired
in three months. My first reaction
was, “What have we done wrong
to merit this fairly drastic action?”
Were we overbilling, overutilizing or
practicing substandard medicine in
some other way?
A telephone call to the company
set the record straight. They had
no complaints about the services
we were delivering; rather, they had
made the decision to hire a nurse
practitioner to care for the dermatologic needs of their enrollees and
saw no reason to have dermatologists on their provider panels.
How had this come to pass?
Obviously, they have made a financial decision with little consideration
about quality patient care. However,
the publicly stated rationale for this
move would be easy to predict.
Moving to extenders
For many years, increasing
numbers of physician extenders
have been employed by dermatologists around the country. These
providers are touted as skilled in
caring for all kinds of skin problems
and may even have more time to
devote to each patient. Based on
the angry letters I received from
several physician assistants and
nurse practitioners after an earlier
editorial on the subject, many of
these people are of the opinion
that they know as much and can
perform as well as physicians in the
management of skin disorders.
vOL. 33, nO. 1
advertising
editorial
DispLay aDs Inquiries involving advertising
should be directed to:
Director
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chief executiVe officer Joe Loggia
executiVe Vice presiDeNt,
chief aDMiNistratiVe
officer Tom ehardt
Increasing numbers
executiVe Vice presiDeNt,
chief MarketiNG officer Steve Sturm
of physician extenders
executiVe Vice presiDeNt,
fiNaNce &
chief fiNaNciaL officer Ted Alpert
have been employed
presiDeNt Andrew Pollard
executiVe Vice presiDeNt Georgiann Decenzo
executiVe Vice presiDeNt Chris Demoulin
by dermatologists
executiVe Vice presiDeNt Danny Phillips
executiVe Vice presiDeNt Ron Wall
around the country.
executiVe Vice presiDeNt eric Lisman
Vice presiDeNt,
MeDia operatioNs Francis Heid
Vice presiDeNt,
GeNeraL couNseL Ward D. Hewins
Let us create a fictitious account
executive at one of the insurance
companies that contracts with
medical groups. He has a one-week
history of a pruritic eruption and
calls for an appointment with his
dermatologist. The dermatologist
is too busy to see him promptly, so
he arranges to be seen by a physician extender in the office. She
diagnoses the problem as a fungal
infection and treats him with a
topical medication.
This patient leaves the office
thinking he has just saved himself
some time and perhaps some
money by not being seen by the
dermatologist. He concludes that
this may be the future of specialty
medicine and that he can save
his company lots of money by
changing the pattern of referrals
away from the expensive physicians
from our board see page 6
Vice presiDeNt,
huMaN resources nancy nugent
chief iNforMatioN
officer J. vaughn
Dermatology Times (Print: ISSN 0196-6197, Digital ISSN 2150-6523) is published monthly by Advanstar Communications Inc., 131 W. First St.,
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Cover credit: Doctor talking to patient:Getty Image/ Rob Lewine; Two doctors standing:Getty Image/ Photodisc/
Siri Stafford
PRINTED IN
U.S.A.
6
Dermatology Times |
from our board from page 4
the 10th patient of the day presents
with a complicated problem, I will put
my money on the dermatologist every
time.
toward cheaper care.
At the risk of further antagonizing
I still have the strongly held opinion that
dermatologists are superior to non-dermatologist
physicians and physician extenders in caring for the
wide range of minor and major skin problems.
dermatologic physician assistants and
nurse practitioners, what the account
executive/patient failed to factor into
the equation is the overall quality of
care.
I still have the strongly held opinion
that dermatologists are superior to
non-dermatologist physicians and
physician extenders in caring for the
wide range of minor and major skin
problems. The first nine patients of
I am in favor of
physician assistants
and nurse practitioners
assisting in the care of
our patients, but the
range of their duties must
be clearly delineated.
the day may have routine problems
such as warts and mild acne. When
More on the horizon
If you think that our experience with
this one insurance carrier is an isolated
aberration, then you are not looking
into the future with a clear and realistic
view. I would predict that nearly all who
deal with patients whose insurance
carrier pays the bills will be faced with
this issue in the near future.
As a specialty, we need to address
this perception problem before
dermatology becomes marginalized
as unnecessary. A public education
program organized by the American
Academy of Dermatology would be
an excellent starting point. The public
needs to know that we are highly
trained professionals who care for
the full range of problems of the skin,
hair and nails. The academy needs to
explain to consumers that we provide
services that no one else can do as
well.
Second, we should stop the practice of promoting the services of physician extenders as equal to those of
dermatologists. I am in favor of physician assistants and nurse practitioners
January 2012
assisting in the care of our patients,
but the range of their duties must be
clearly delineated, not only internally,
but also to the patients themselves.
A seemingly trivial but potentially
effective means of promoting this
idea is to identify who is a physician
and who is not a physician in the
office. This can be done by having
each provider wear a name tag that
clearly identifies his or her training.
A few states already are mandating
this; it makes perfect sense to me. For
example, your name tag might read,
“Jane Smith, physician,” while your
nurse would have a name tag such as,
“Joe Jones, nurse” (even if he has a
Ph.D. in nursing, which would make
him technically a doctor but would be
misleading at best).
For those who contemplate a
primarily cash-only practice in the
future, this discussion might seem
somewhat quaint.
For the rest who wish to maintain
a relationship with patients whose
insurance companies are the primary
payers, it is critically important that
resources be mobilized to justify the
existence of dermatologists as skilled
specialists who contribute uniquely to
the well-being of the patients. DT
Norman Levine, M.D.
DT editorial advisory board
Zoe Diana Draelos,
M.D., is consulting
professor of
dermatology, Duke
university School of
Medicine, Durham,
n.C.
Norman Levine,
M.D., is a private
practitioner in
Tucson, Ariz.
ronald G.
Wheeland, M.D., is
chief of dermatologic
surgery, Department
of Dermatology,
university of Missouri,
Columbia, Mo.
elaine siegfried,
M.D., is professor
of pediatrics and
dermatology, Saint
Louis university
Health Sciences
Center, St. Louis.
DT
editorial
editorial
council
council
Dr. Joseph
Bikowski
Dr. Roy
Geronemus
Dr. Patti
Farris
Dr. David
Goldberg
Dr. Ranella
Hirsch
Dr. Seth
Matarasso
Dr. Joel
Schlessinger
Dr. James
Spencer
Dr. Helen M.
Torok
Dr. Philip
Werschler
The Dermatology times editorial Advisory Board and editorial Council qualify the editorial content of the magazine. Members review meeting programs;
suggest story topics, special reports and sources; evaluate manuscripts; conduct interviews and roundtables; and counsel editors as questions arise.
January 2012
|
legal eagle
DermatologyTimes.com
David Goldberg,
M.D., J.D., is director
of Skin Laser &
Surgery Specialists
of New York and New
Jersey; director of laser
research, Mount Sinai
School of Medicine; and
adjunct professor of law,
Fordham Law School.
Picture-perfect
D
Photography, fillers and patient privacy — where does one draw the line?
r. Camera has a large medical and cosmetic dermatology practice. He is known
to take high-quality photos
of everything he does.
Two years ago, he treated a patient
with dermal fillers. Prior to treatment, Dr.
Camera obtained consent to perform the
procedure, and he took pre-procedure
photographs.
One month later, Dr. Camera also took
post-treatment photos of the patient. The
results were terrific. One year later, the
photos were used for local advertising
purposes. The patient was horrified and
filed a lawsuit alleging a HIPAA violation.
What is this all about?
The use of patient photography,
videotaping, digital imaging and other
visual recordings during cosmetic
filler treatment is common. Although
cosmetic patient photographic documentation is common, liability issues
need to be considered and federal regulations observed.
Without proper precautions during
such a healthcare encounter, patient
photography may make an aesthetic
physician liable for invasion of privacy.
U.S. courts have imposed liability
primarily when the provider has exploited
the patient for commercial benefit.
However, courts have also imposed
liability when the patient’s name or likeness was used for non-commercial
purposes, finding that even taking a
picture without the patient’s expressed
consent was an invasion of privacy.
Privacy, please
Physicians may also be subject to
liability for publishing photographs or
other images under the type of invasion
of privacy known as public disclosure
of embarrassing private facts. In one
case, the court ruled that a physician
had invaded a patient’s privacy by using
“before” and “after” photographs of
her face to demonstrate the effects of a
facelift.
The use of the photographs publicized the fact the patient had had a
facelift, which she found embarrassing
and distressing. Before allowing patient
photography, it is important that a physician consider why it is being done and
how the images will be used.
The U.S. standards for privacy of
individually identifiable health information, also known as the final privacy rule
from the Health Insurance Portability
and Accountability Act of 1996 (HIPAA),
address photographs and similar images
both directly and indirectly. Section
160.103 defines health information in a
manner that implies inclusion of patient
photography:
“Health information means any information, whether oral or recorded in any
form or medium, that
“1. is created or received by a healthcare provider, health plan, public health
authority, employer, life insurer, school or
university, or healthcare clearinghouse;
and
“2. relates to the past, present, or
future physical or mental health or condition of an individual; the provision of
healthcare to an individual; or the past,
present, or future payment for the provision of healthcare to an individual.”
According to Section 164.514(b)(2),
Implementation Specifications: Requirements for Identification of Protected
Health Information, photographic and
comparable images are explicitly noted
as an item to be removed during de-identification in order for records to avoid the
protected health information.
Clear consent
In offices where cosmetic fillers are
given, patient photography is used
routinely to document patient care. In
such a setting, the practice of patient
photography should be included in the
United States HIPAA-mandated notice
of information practices, as well as in
the consent for treatment signed by all
patients. It is advised that a consent
paragraph, such as the one below, be
routinely used.
“I understand that photographs,
videotapes, digital, or other images may
be recorded to document my care, and I
consent to this. I understand that (physician’s name) will retain the ownership rights
to these photographs, videotapes, digital,
or other images, but that I will be allowed
access to view them or obtain copies. I
understand that these images will be stored
in a secure manner that will protect my
privacy and that they will be kept for the time
period required by law or outlined in (physician’s name)’s policy. Images that identify
me will be released and/or used outside the
office only upon written authorization from
me or my legal representative.”
It should be noted that such a consent
does not authorize the use of the images
for other purposes, such as teaching or
publicity. A separate consent for photography form should be used for such
purposes.
In addition, HIPAA regulations
require patient authorization for the
release of protected health information,
which includes patient photography for
purposes beyond treatment, payment
and healthcare operations.
Since photography is routinely undertaken when dermal fillers are injected,
the above paragraph may be incorporated into the consent form for that
procedure.
Written authorization should be
obtained before photographing patients
for medical education, staff teaching, or
publicity purposes. The patient or his/
her legal representative should sign
and date the authorization form. Anyone
other than the patient who has the legal
authority to sign should indicate his
or her relationship to the patient. The
signature should be witnessed, and the
witness’ signature should be included on
the authorization form.
Dr. Camera erred in not obtaining a
HIPAA-compliant photography consent
form before publishing the photos. DT
7
THE SCIENCE OF HYDRATION
expl o r i ng
aquaporins
In 2003, the Nobel Prize in
Chemistry was awarded for the
discovery of aquaporins, a family
of protein channels that transport
water rapidly between cells,
enabling them to regulate water
volume and internal
osmotic pressure.1,2
Aquaporin 3
(AQP3) is
the most
abundant
aquaporin
in the skin
Aquaporin 3 (AQP3)
and is
responsible for selectively
transporting both water and
glycerol between keratinocytes.3,4
In the deeper layers of the
epidermis, where cells are highly
permeable, there is strong
expression of AQP3, while in the
impermeable stratum corneum,
AQP3 channels are absent.2,3
Understanding the water network
beneath the stratum corneum may
have implications in the treatment
of xerosis. Rebuilding the natural
hydration network is one
mechanism that could enable
the skin to maintain optimal
hydration, even in the deeper
epidermal layers.2-4
At Beiersdorf, we are excited
about exploring hydration at
the molecular level and delivering
solutions that work with the skin’s
natural processes. Our commitment
to research has produced a
continuous line of innovations
that have fueled our passion
for skin science for more than
125 years.
In healthy young skin, AQP3
is abundantly expressed in
keratinocytes within the viable
epidermis.3 But in skin that has
become dry, due to sun exposure
or aging, AQP3 levels are
measurably decreased.2
©2011 Beiersdorf Inc.
Makers of Eucerin® and Aquaphor®
10
washington & you
Dermatology Times
|
January 2012
Bob Gatty, former
congressional aide,
covers Washington for
businesses specializing
in healthcare and related
issues. Contact him at
bob@gattyedits.com.
Battle brewing
T
Medicare reimbursement controversy expected to escalate in new year
he battle over Medicare
spending and how much
dermatologists and other
physicians are paid for treating
Medicare patients is expected to escalate
in 2012, with major policy decisions to be
faced by Congress in the heat of congressional and presidential election campaigns.
A 27.4 percent reduction in Medicare
payments was set to be implemented
starting Jan. 1 unless Congress could
reach a solution in December. In recent
years, temporary one-year “fixes” have
been implemented to avoid such drastic
reductions, but often not until the deadline
had passed.
The Obama Administration promised
that such deep cuts — originally slated for
29.5 percent but reduced in the final rule
from the Department of Health and Human
Services — would not be allowed to take
place. At press time, veteran Washington
observers expected another temporary
reprieve would be implemented.
“We have not and will not let deep
cuts to doctors’ payments occur,” said
HHS Secretary Kathleen Sebelius. “The
Obama administration is 100 percent
committed to fixing the flawed Medicare
payment system and protecting Medicare beneficiaries and doctors.”
Since the bipartisan “super
committee” established by Congress in
last year’s Budget Control Act failed to
agree on a plan to slash $1.2 trillion from
the U.S. budget as required by the law,
it did not deal with reforming the Medicare payment system and left in place
a fallback maximum 2 percent acrossthe-board cut that is slated to take effect
in 2013. The act exempted Medicare
patient benefits from being affected by
the automatic spending cuts, leaving
healthcare providers “on the chopping
block,” in the words of a press release
from the American Medical Association.
However, unless a sharply divided
Congress can overcome election-year
politics and find a way to cover the estimated $300 billion cost of replacing the
sustainable growth rate (SGR) formula
used to determine Medicare physician
fees, still further reductions will be threatened again for next year under that system.
MedPAC blues
Meanwhile, physician groups, including
the American Academy of Dermatology
Association, are strongly opposing a
proposal by the Medicare Payment Advisory Commission that would eliminate the
SGR but slash the conversion factor for
specialist services by 5.9 percent each
year for three years, followed by a freeze
for seven years. The cumulative effect,
the AADA says, would be 18 percent over
those first three years. For primary care
physicians, Medicare payments would
simply be frozen over 10 years.
The AADA endorsed a letter to the
House of Representatives leadership
in mid-November that was signed by
approximately 80 House members
from both parties opposing MedPAC’s
recommendations. Lawmakers said
that proposal “would threaten the ability
of seniors and disabled Americans to
access care from qualified physicians
and providers when faced with a potentially life-altering or even life-threatening
illness.
“We are committed to finding a
legislative solution that addresses the
shortcomings of the current Medicare
payment system, but we believe we must
do so in a way that improves access
to care — not in a manner that makes
an already tenuous situation worse,”
said the congressional letter, initiated
by Reps. Michael C. Burgess, M.D.
(R-Texas), and Gene Green (D-Texas).
Revisiting IPAB
Ironically, the failure of the super
committee to find a budget solution
appears to bolster the argument of
supporters of the Independent Payment
Advisory Board, created by the Patient
Protection and Affordable Care Act, the
healthcare reform law that is now being
challenged by opponents before the U.S.
Supreme Court.
Opposed by the AADA and most
other physician organizations, the IPAB’s
purpose is to make recommendations for
controlling the growth of Medicare. The
IPAB’s recommendations for reducing
Medicare spending will take effect unless
Congress passes and President Obama
signs alternative proposals to save the
same amount of money, or unless the
Senate votes with a three-fifths majority
to reject the proposals. Further, IPAB’s
changes cannot be overruled by the
administration or the courts. Currently,
MedPAC’s recommendations must be
approved by Congress in order to take
effect.
IPAB supporters argue that the panel
must have such authority because the
current system is too susceptible to
lobbying and influence from those who
would be harmed by its actions, such as
physicians. They contend that the failure
of the super committee to act is further
evidence of the need for the IPAB.
Of course, the AADA and other physician groups contend that Congress
should not yield its power to a board
composed of unelected officials who
need not answer to the people.
While the challenge of the healthcare
law now before the Supreme Court
centers on the mandate for healthcare coverage that is contained in the
measure, the IPAB provision would be
eliminated should the law be declared
unconstitutional. However, if left intact,
the IPAB’s first recommendations for
cuts must be submitted to Congress by
Jan. 15, 2014, and will become effective
— unless Congress overturns them — by
the following January.
How Congress and the White House
responds to all of these issues in this
2012 election year remains to be seen.
Dermatologists, who account for only
1 percent of the physician population
but nearly 4 percent of overall Medicare
expenditures, have a lot at stake. DT
12
on call
Dermatology Times
|
January 2012
Karen Nash, a print
and broadcast media
medical reporter and
former TV medical news
reporter, has been writing
On Call for more than
20 years. Contact her at
welshman@sio.midco.
net.
Weathering the storm
A
Derms delay retirement, reduce staffing as they await economic turnaround
fter more than two years of
volatility and a 7,000-point
drop, the U.S. stock market
closed at a 12-year low of
6,547 in March 2009. Many retirement
accounts across the country were hard
hit. In the two-and-a-half years since, the
Dow Jones average has shown signs of
recovery, finishing well above 11,000, even
flirting with the 12,000 figure.
On Call wondered how dermatologists fared through the financial crisis and
whether their retirement plans have been
impacted by the uncertain market and
economy. Have they been making adjustments in their practices to better prepare
for retirement down the road?
Certainly, some doctors have been hit
much harder by the economic downturn
than others, and a physician’s geographic
location may play a role in the severity of
the impact, while others say they were a bit
more fortunate in their financial planning.
Pondering retirement
C. Ralph Daniel III, M.D., in Jackson, Miss.,
says he has no definite plans to retire, but it
is a viable option he could choose.
“Over the first 25 years I was in practice I did 70 hours a week,” he says. “I did
hospital call, was on call every other night
and every other weekend. After 25 years I
quit doing hospital call and cut back to 38
to 40 hours a week. I’m not seeing hospital
patients and doing less call. As long as
my health holds out, I’ve no plans to retire
per se. As long as I can do this and I’m
enjoying this, this is good.
“The economy has not impacted my
plans because I’m a very conservative
investor,” Dr. Daniel says. “I do over 80
percent of my investing in AAA-rated
things. I don’t make a lot of money, but I
haven’t lost a lot of money. A number of
my friends are planning to work longer
than they originally had; they don’t have
definite cutoff dates like they used to have
because their portfolios have gone down.
Most people don’t follow the rule that you
should have your age in bonds, but I’ve
always been much more conservative.”
Dr. Daniel says his practice also
benefits from getting older. “As I get older
my patients get
Dr. Daniel
older, and as my
patients get older
they have more
skin cancer,” he
says. “Of course,
skin cancers are
coming back for
repeat visits, and
over 30 years you
end up having a lot
of people who have return appointments
because they need skin cancer checks.
Retirement isn’t an option at the
moment, Dr. Young says.
“I can’t afford to retire,” he says. “I used
my retirement fund to keep my practice
afloat. I drained $800,000 from my retirement plan, closed my office in an office
complex, let two long-time employees go,
and built a very nice home-based office.”
Now, he says, “I’m basically a one-man
dermatology operation. I do the pharmaceutical preauthorization with insurance
companies; I write the prescriptions and
do the charting. I’m the one putting things
in the bottle, staining the specimen, writing
in the lab book. I escort the patient in,
make the next appointment and walk him
out the door — everything soup to nuts.
“I probably epitomize the California economy right
now. My practice dropped off about 40 percent in
2008 to 2009 and never really recovered.”
Edward Young, M.D.
Los Angeles
As you do more procedures, you actually
do better income-wise.”
One-man operation
Many other dermatologists were not as
fortunate, even when they had saved,
because outside factors intervened. In Los
Angeles, Edward Young, M.D., didn’t lose
his retirement account as stocks fell, but
found he had a more urgent need for the
funds as a direct result of the economic
downturn, he says.
“I probably epitomize the California
economy right now. My practice dropped
off about 40 percent in 2008 to 2009
and never really recovered,” Dr. Young
says. “Even patients with Medicare and
secondary insurance held off coming in
because of lab fees and co-payments.
I specialize in moles and skin cancer
removals, mainly in geriatric patients,
and instead of annual check-ups, they’re
waiting two to three years to come in.”
They see the doctor every second they’re
in the office.
“It makes me a better doctor because
everything in the office filters through
my eyes. You learn a lot more about your
patients because you don’t have ancillary
staff doing half the charting. It brings me
closer to my patients because I remember
them more intensely. There’s nothing in
the office I haven’t done, except billing,
which I’ve contracted out for 15 years.”
Dwindling funds
In South Florida, Barry I. Resnik, M.D., is
still in his 40s, but he says he is not sure
how his retirement savings will recover
after being caught between stock prices
and wanting to use funds he had put away.
“We had a nest egg, now it’s more like
a nest peanut,” he says. “Our investments
got hit by about 40 percent and they’ve
only come back by about 10 to 20 percent.
At the same time, we have one child in
on call see page 17
aquapharm.com
MAD-1102
14
Dermatology Times
|
January 2012
research stat
abstracts from that pile of peer-reviewed journals on your desk
Oncology
◾ Smoking Strongly aSSociated
with nonmelanoma Skin cancer
cancer causes & control
november 2011
Cigarette smoking is more strongly associated with squamous cell carcinoma
(SCC) than basal cell carcinoma (BCC),
especially among women, according to a
study published online Nov. 19 in Cancer
Causes & Control.
Researchers with Moffitt Cancer
Center, Tampa, Fla., recruited 698
participants, including patients with
BCC and SCC from a university dermatology clinic and controls who had no
history of skin cancer and who screened
negative for skin cancer upon physical
examination.
Participants completed selfadministered questionnaires regarding
smoking and other risk factors. The
researchers found that after adjusting
for sex, age and other skin cancer risk
factors, ever smoking wasn’t associated
with BCC (odds ratio = 1.26, 95 percent
confidence interval = 0.83-1.92). For
SCC, however, the association with
smoking was significant (OR = 1.97, 95%
CI = 1.19-3.26). The figures rose with
increasing cigarettes per day and packyears smoked.
Among women specifically, smoking
was strongly associated with SCC (OR
= 3.00, 95% CI = 1.02-8.80), but not with
BCC (0.98, 95% CI = 0.39-2.46).
http://www.springerlink.com/
content/9783444k55722502/
◾ ipilimumab Safe in melanoma
patientS with brain metaStaSeS
melanoma research
december 2011
Ipilimumab appears to be safe and efficacious in patients with melanoma who
have stable brain metastases, according
to a small retrospective study published
in the December issue of Melanoma
Research.
Citing a growing body of evidence that
suggests ipilimumab, which blocks cytotoxic T-lymphocyte antigen-4, has activity
against brain metastases, researchers
with Moffitt Cancer Center, Tampa, Fla.,
conducted a retrospective analysis of
data from a phase 2 study of the drug
in patients with advanced melanoma.
Twelve of 115 patients randomized in the
parent trial were diagnosed with stable
brain metastases at baseline.
Two of the 12 patients achieved partial
response from ipilimumab, while three
had stable disease. Both patients who
achieved partial response and one with
stable disease were alive at the last followup, with survival time of more than four
years. Median overall survival of the 12
patients was 14 months. Central nervous
system-related adverse events, specifically cerebral edema and convulsion/
seizure, occurred in two patients.
“Although the present study is limited
by the fact that it is a retrospective
analysis of a small number of patients, the
results provide further evidence for the
safety and efficacy of ipilimumab in melanoma patients with stable brain metastases,” the study authors wrote.
http://journals.lww.com/
melanomaresearch/Abstract/2011/12000/
Safety_and_clinical_activity_of_
ipilimumab_in.9.aspx
Clinical Dermatology
◾ otc topical antibioticS
may encourage Spread of mrSa
emerging infectious diseases
october 2011
The spread of methicillin-resistant
Staphylococcus aureus USA300 (MRSAUSA300) may be influenced by the use
of over-the-counter (OTC) topical antibiotics, according to a study published in
the October issue of Emerging Infectious
Diseases.
Researchers with Aichi Prefectural
Institute of Public Health, Nagoya, Japan,
tested 259 MRSA isolates and two
USA300 ATCC type strains in Japan for
susceptibility to bacitracin and neomycin,
commonly found in OTC antibacterial
ointments. They determined that although
the drug combination of bacitracin and
neomycin was effective against many
strains of MRSA, there was resistance
against the drugs in the USA300 strain.
The study authors noted that topical
antibiotics containing bacitracin and
neomycin are “widely used” in the United
States, but in Japan, ointment use is not
widespread, and, “As a result, the selective pressure that leads to bacitracin and
neomycin resistance is weak in Japan.
“In each country, susceptibilities
of MRSA-USA300 to bacitracin and
neomycin should be thoroughly investigated, and relationships between the
dissemination of MRSA-USA300 and the
usage of OTC drugs should be clarified,”
the authors wrote.
http://wwwnc.cdc.gov/eid/
article/17/10/10-1365_article.htm
◾ peptideS can kill off
Malassezia syMpodialis
letters in applied microbiology
January 2012
Certain peptides can kill off the yeast
Malassezia sympodialis, which can
trigger atopic eczema, seborrheic
eczema and dandruff, according to a
study published in the January issue of
Letters of Applied Microbiology.
To examine whether different antimicrobial peptides and cell-penetrating
peptides can inhibit the growth of M.
sympodialis, researchers at the department of neurochemistry, Stockholm
University, used microdilution assay and
plate counting to investigate the fungal
activity of 21 different antimicrobial
peptides and cell-penetrating peptides.
They found that five cell-penetrating
peptides and one antimicrobial peptide
demonstrated fungicidal activity at
submicromolar concentrations.
Additionally, there was no membrane
damage on the human keratinocytes
after peptide treatment, the investigators
determined. The authors concluded that
while several cell-penetrating peptides
are nontoxic to mammalian cells, they
possess growth inhibitory activity on
“the very stringent yeast” M. sympodialis.
The authors noted that their findings
about the particular peptides “open up
the possibility to use these in the treatment for AE, SE and dandruff,” they
wrote. “To our knowledge, this is the
first time peptides have been identified
as antifungal agents against M. sympodialis. Further studies to elucidate the
mechanism are warranted.”
http://onlinelibrary.wiley.com/doi/10.1111/
j.1472-765X.2011.03168.x/abstract
Miscellaneous
◾ immune SyStem containS
protective memory cellS
nature
november 2011
A type of cell in the human immune
system can be activated by tissues within
the body to serve as a reminder not
to attack its own cells, molecules and
organs, according to findings reported
online Nov. 27 in the journal Nature.
According to the University of California, San Francisco, researchers with
the university’s department of pathology
used a mouse model of autoimmune
disease to uncover a role in immune
system memory for activated T regulatory cells. Over time, the skin defends
itself from autoimmune attacks by activating a small fraction of T regulatory
cells, the investigators determined. The
cells that the researchers tracked circulate in the blood and are counterparts of
the memory cells that fight of microbial
bodies after vaccination or repeated
exposure to the same pathogen,
according to the university.
The researchers genetically engineered a strain of mice in which they
could switch on or off the production
of ovalbumin, a self protein in the skin.
The mice were triggered to produce an
overabundance of the protein, provoking
an autoimmune response. The presence
of the protein also triggered activation
of T regulatory cells, which proliferated
and became a more potent form to better
suppress autoimmunity, according to
the study.
The study investigators said the
findings suggest the potential for using
specialized memory cells during treatment to help prevent attacks on specific
molecular targets.
“These findings provide a framework
for understanding how T regulatory cells
respond when exposed to self antigen in
peripheral tissues and offer mechanistic
insight into how tissues regulate autoimmunity,” the study authors wrote.
http://www.nature.com/nature/journal/
vaop/ncurrent/abs/nature10664.html
◾ phySicianS learn equally
from SucceSSeS, failureS
ploS one
november 2011
High and low performing physicians
show distinct patterns of learning, with
high performers demonstrating learning
equally from both successes and failures, according to a study published
online Nov. 23 in PLoS One.
At the University of Toronto,
researchers used functional magnetic
resonance imaging in 35 experienced
physicians as they learned to choose
between two treatments in a series of
virtual patient encounters. The learning
model for each participant was based
on his or her observed behavior, and the
model was divided clearly into “high”
and “low” performers.
In the high performers group, participants demonstrated small but equal
learning rates for positive outcomes
and failures (no response to treatment).
The low performers, however, showed
very large and asymmetric learning
rates, and appeared to learn significantly more from successes than from
failures. This tendency, according to the
study, resulted in suboptimal treatment
choices.
Along with the behavioral findings,
the high performers showed larger and
more sustained blood oxygenation leveldependent responses to failed versus
successful outcomes in the dorsolateral
prefrontal cortex and the inferior parietal
lobule. Low performers demonstrated
the opposite response profile.
The study authors suggested the
differential brain activations between
high and low performers may be developed into biomarkers to help identify
efficient learners on novel decision tasks
in medical or other applications.
“These results suggest that high
performers’ brains achieve better
outcomes by attending to informative
failures during training, rather than
chasing the reward value of successes.”
http://www.plosone.org/article/
info%3Adoi%2F10.1371%2Fjournal.
pone.0027768
◾ med StudentS fail to id
hand hygiene indicationS
american Journal of infection
control
december 2011
Medical students preparing to enter the
clinical phase of their careers lack knowledge about proper indications for hand
hygiene, according to findings published
in the December issue of the American
Journal of Infection Control.
Investigators with Hannover Medical
School, Germany, reviewed beliefs of 85
medical students regarding various hand
hygiene-related topics, at the time before
the students entered the clinical phase of
their education. The students were asked
to identify correct hand hygiene indications from a list of seven possibilities.
Five of the seven were true indications.
Additional topics surveyed were
beliefs on hand hygiene compliance in
various medical departments, potential
reasons for noncompliance and the
potential for nosocomial infection reduction with 100 percent hand hygiene
compliance.
All true and false indications were
correctly identified by only 21 percent
of respondents, but 67 percent of them
were able to correctly identify the five
hand hygiene indications, according to
the study results.
http://www.ajicjournal.org/article/S01966553(11)00092-7/abstract
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16
DT news
Dermatology Times |
January 2012
... From page 1
Supply & demand: Long wait times continue for patients
not unusual to get daily emails, postcards and sometimes phone calls from
recruiting companies. Actually, even
after I have started my practice, I am
still approached by recruiters for dermatology positions across the country.”
Longstanding problem
Today’s dermatology workforce is in
stable chronic undersupply, according
to A le x a B o er
Dr. Kimball
Kimball, M.D.,
M . P. H . , a s s o ciate professor,
Harvard Medical
School, Boston,
a nd aut hor of
severa l papers
on the workforce
topic.
That’s despite
the fact that dermatology is a highly
sought-after specialty among medical
students and a field that, in 2009,
offered an average starting salary of
$325,000, according to the Medical
Group Management Association.
The reasons for the shortage are
complex, experts say, and include
restrictions on the number of available residency slots as well as new
doctors’ geographic preferences after
residency.
“I am still approached
by recruiters for
dermatology positions
across the country.”
Kathleen Beckum, M.D.
Birmingham, Ala.
“Si mply, t here is substa nt ia l
demand that we can’t meet. There
are substantial geographic variations
in supply and demand,” Dr. Kimball
says. The shortages are most apparent
in medical and pediatric dermatology,
she says. In general, most dermatologists believe there is enough cosmetic
and surgical capacity.
Jack Resneck Jr., M.D., associate
professor of dermatology and health
story highlights
◾ Derm workforce undersupplied
◾ Patients face long wait times
even where numbers adequate
◾ Physicians urge Congress
to protect education funding
policy at University of California, San
Francisco, says evidence points to a
persistent shortage of dermatologists
in most areas of the United States.
“Even in some
Dr. Resneck
of the most
popular places
to practice,
where the ratio
of der matolo gists to population is highest,
wa it-t imes for
patient appointment s rem a i n
long, and the number of dermatologists seeking associates far exceeds
the number of residency graduates,”
says Dr. Resneck, who has published
extensively on the topic.
He notes, however, that there are a
limited number of geographic areas
where a smaller number of dermatologists seems adequate.
“This probably is due to a higher
demand for dermatologic services
in some areas. In particular, patient
demand for surgical dermatology and
cosmetic dermatology seems to vary
the most,” he says.
Dr. Resneck says the shortage has
been relatively stable over the past
decade.
“There has been a slight decline
in appointment wait times, but the
change has been surprisingly small,
given both the influx of thousands
of non-physician clinicians into
dermatology and the recent recession,” he says.
population is the ratio typically
needed to support a practitioner,
says study co-author Darrell S. Rigel,
M.D., clinical professor of dermatology at New York University, New
York.
What varies greatly, he says, is
the distribution. While downtown
Boston has the highest density, at 46.9
dermatologists per 100,000, Jamaica,
N.Y., the least dermatologist-dense
area in the country, has only 0.13 per
100,000 people.
But describing
Dr. Rigel
the shortage as
a ma ldistribution problem
is making a
complex is sue
too simple,
e x p e r t s s ay.
Even in the highdensit y a re a s ,
dermatologists
are busy and waits are long.
“The reason you know there’s a
shortage is that there are about 1,500
physician assistants. The reason that
they are in there is (that) there is a
vacuum,” Dr. Rigel says.
T hat ’s t he c a se i n nor t hea st
Ohio. Dr. Brodell, who is professor
o f i nt e r n a l m e d i c i n e , d e r m a tolog y section, Nor t heast Ohio
Medical University, Rootstown, says
colleagues within 20 miles of his practice have hired physician assistants
and nurse practitioners to help with
patient loads.
Another factor, Dr. Rigel says, is
that the burden of some dermatologic
disease is going up. “Skin cancer rates
are rising. … And with the advent of
noninvasive cosmetic procedures …
there’s more demand for dermatology
there, too,” he says.
Residents hold key
Workforce calculus
Currently, there are about 3.2 practicing dermatologists for ever y
100,000 people in the United States,
according to a paper in the July 2010
Archives of Dermatology. Three to
four dermatologists per 100,000
The high demand for dermatologists
fresh out of residencies puts young
doctors squarely in the driver’s seat
— and that fuels the undersupply in
some geographical areas.
Forty-three percent of dermaSupply see page 20
January 2012
|
on call
DermatologyTimes.com
on call from page 12
private college, another one a year-and-ahalf away, and a third right behind.”
The area’s housing market has had an
impact on financial planning, Dr. Resnik
says.
“Living in Florida, the issue has been
exacerbated by the housing collapse,” he
says. “Our home used to be valued at
$1 million; it dropped to $470,000.”
Dr. Resnik says he’s working to retain
the capital in his
Dr. Resnik
savings while
trying to recover
its growth, all while
finding ways to
increase his practice income.
“It goes all
the way from
downsizing and
reducing my
car payment and thinking about how to
reduce overhead. I’ve cut staff and don’t
offer insurance to staff anymore, and we
work harder because we’re making do
with less. Then you talk about reducing
your electric bill,” he says. “I have always
been ‘green,’ but it’s now green both in
terms of being good to the environment as
well as being good to my bank account. I
want my staff to turn the lights off at lunchtime and turn their monitors off at the end
of the day. I know it doesn’t save a lot, but
every little bit helps. I want them to save
their paperclips and don’t want them to
use three gauzes when one will do.”
Dr. Resnik has strong ties in South
Florida, and time to recover financially,
but he says the economy has made
him consider options he might not have
thought about before.
“One of the bellwethers of the difficulty
we’re experiencing is I now read those
recruitment emails from places like North
Carolina, Iowa and the Dakotas,” he says.
“You think, ‘If I did
Dr. Dattner
that for a couple
of years I’d be a lot
more comfortable.’
But then I look at
the roots my wife
and I have here,
and it becomes
a lot less easy to
contemplate. But
nothing is off the
table — whatever we have to do.”
32 years in practice, “I don’t know if I can
afford to retire,” he says. “I took some
losses with the economy. It’s come back a
little bit, but nowhere near what I had had.
I had no definite plans to retire because I
enjoy my work, and now I’m actually more
concerned that government regulations
will become so difficult that I won’t afford
to practice either.
“The economy has also affected me
because since patients often can’t use
insurance, they’ll come in but can’t afford
follow-up,” he adds. “It’s frustrating to
hear Congress talk about $250,000 to
million-dollar treatment protocols to give
oncology patients one quality year of life,
where I can change a person’s life quality
for $3,000 to $4,000 a year, and they can’t
afford to pay me.” DT
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Looking toward the future
Alan Dattner, M.D., has a holistic dermatology practice in New York City and
doesn’t always qualify for insurance. After
Obagi, Obagi for Life, and the Obagi logo are registered trademarks of OMP, Inc. Distributed by OMP, Inc.
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17
© 2011 Genentech USA, Inc. All rights reserved. HED0000726500 Printed in USA.
Genentech is investigating the molecular basis
of skin cancers such as advanced BCC.
References: 1. Jarell AD, Mully TW. Basal cell carcinoma on the ear is more likely to be of an aggressive
phenotype in both men and women. J Am Acad Dermatol. In press. 2. Habif TP. Premalignant and
malignant nonmelanoma skin tumors. In: Habif TP. Clinical Dermatology. 5th ed. St Louis, MO: Mosby
Elsevier; 2009. 3. Parizel PM, Dirix L, Van den Weyngaert D, et al. Deep cerebral invasion by basal
cell carcinoma of the scalp. Neuroradiology. 1996;38:575-577.
20
DT news
Supply from page 16
tologists practice within 100 miles
of their residency training sites,
according to a study Dr. Resneck
co-authored in the September 2011
issue of Archives of Dermatology.
Programs in New York City, as well
as several in California and Florida,
were most likely to retain trainees in
those states, researchers found after
analyzing post-residency migration
patterns.
Dr. Beckum is an example. She
and her husband have settled in
Birmingham,
Dr. Brodell
Ala., where she
accepted a post
as associate
professor at the
Un i v e r s i t y o f
Alabama.
“My husband
and I both love
Birmi ng ha m,”
she says. “It is has
a great cost of living, excellent schools
and career opportunities for both of
us. Birmingham is also a good location for us both to visit our families
easily.”
Given t he high patient need,
persistently long appointment wait
times, and plentiful job opportunities
in most areas, residency graduates
are able to practice where they want
to live, rather than where shortages
are most severe, according to Dr.
Resneck.
Previous studies have consistently
shown that dermatology residency
graduates consider location their first
priority, he says. And studies in other
specialties have shown that physicians “tend to continue to populate
desirable areas, even if those areas
are saturated.”
It’s complicated
As complex as the workforce problems are, the solutions are even
trickier.
The number of dermatology residency training positions has risen
in recent years, according to Dr.
Dermatology Times |
Rigel. In 2011, 402 dermatology residents graduated from U.S. medical
programs and 36 from doctor of
osteopathic programs, according to
the Yearbook of Dermatology 2011.
While the number is expected to dip
to a total of 405 total in 2012, it should
rise to 445 in 2013, according to the
yearbook.
But that won’t solve the problem.
“At some point that will make a difference, but … it takes years to ramp up
the number of people,” Dr. Rigel says.
Experts say more will be needed to
ease the burden on practitioners. One
solution, Dr. Rigel says, is to produce
more dermatologists by loosening
residency restrictions. The difficulty
there, he says, is not that the programs
are against adding residents, but that
hospitals won’t increase residency
slots because of fixed government
funding.
January 2012
Consequences
physician assistants.”
In t he mea nt i me, busy der matologists must triage appointment
requests. Dr. Brodell says he has
trained his staff to listen to patients
who call his office, to help determine
who should be seen immediately and
who can wait.
“If you tell my staff that you have a
black changing lesion on your cheek
that has grown twice the size in the
last month, my staff knows to get
you in. … (And) if other doctors in
the primary care community call
us and say somebody needs to be
seen today, we see those people that
day,” he says.
Dr. Kimball says doctors can ease
some overscheduling by more carefully managing follow-up patients,
“being as evidence-based as we can
in how often we see them.”
Seeing t hese pat ients less
frequently, but within their medical
needs, would open more appointment
slots, she says.
“If you see an acne patient three
(times) a year, instead of four times,
you probably don’t affect their care
much, but you do open up another
visit for someone else,” she says.
Darrell S. Rigel, M.D.
New York University
Up to physicians
“The reason you know
there’s a shortage is that
there are about 1,500
To make matters more unstable,
that funding is uncertain.
“Residency positions are largely
f u nde d t h rou g h t he Me d ic a re
program, and the number of funded
positions was frozen by Congress
several years ago,” Dr. Resneck says.
“As part of current deficit negotiations, one of the items being considered is a reduction in the number of
(graduate medical education) slots,
which would further exacerbate the
problem.”
The American Academy of Dermatology, concerned about possible
GME cutbacks, was among 40 physician and other organizations that sent
a collaborative letter to Congress in
October, urging protection of existing
Medicare GME funding.
And at the end of the day, it’s up to
dermatologists to make sure that
patients have access to well-trained
practitioners when they need them,
Dr. Resneck says. He notes that
healthcare reform is leading to an
expansion in the number of insured
patients and possible changes in
delivery of medical care, which will
further affect the system.
But failure to accommodate treatment requests, he says, can eventually
impact the specialty — and patients’
health.
“If our patients or referring physicians become too frustrated seeking
appointments with us, they may
begin to look elsewhere, and that
could affect the quality of care,” he
says. DT
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22
DT news
Dermatology Times |
January 2012
...From page 1
Morning: Cancer risk higher in afternoon
the protein is named, Dr. Sancar tells
Dermatology Times.
Dr. Sancar’s earlier work determi ned t hat t he core molecu la r
circadian clock regulates XPA gene
expression and the level of production of the XPA
protei n i n t he
Dr. Sancar
livers and brains
of mice. He
reasoned that it
ought to apply to
the skin as well.
Dr. Sancar first
determined that
this indeed was
t he case, and
t hen exposed
one g roup of a n i m a l s to U V B
when the repair mechanism was
at its functional nadir (4 a.m.) and
another group when the cycle was it
its peak (4 p.m.).
Both groups of animals developed tumors, but the time to first
tumor in the morning group was
shorter (median 19 vs. 21 weeks);
t he y de velope d t w ic e a s ma ny
tumors (24 vs. 12 tumors) in the
25-week observation period; the
average tumor diameter was nearly
twice as large as was seen in the
afternoon group; and there were
five times as many invasive tumors
in the morning group compared to
the afternoon group.
“The main point is that we found
t hat t he same U VB dose is f ive
times more carcinogenic in the
morning than in the afternoon” in
the mouse model, Dr. Sancar says.
At either time point, photoproduct
damage was repaired “about 10-fold
faster than CPD because PP (photoproduct) distorts the DNA more
severely.”
Relating to human cycles
Repair correlated with the level of
XPA; there was substantial repair
during the phase of the cycle when
the level of XPA was high, but little
or no repair when that level was low.
Repair speeded up when the level of
XPA cycled back to high.
story highlights
◾ Study demonstrates greater risk
of skin cancer in afternoon sun
◾ In mouse model, UVB dose was
five times more carcinogenic in a.m.
◾ Sun warnings should remain same
As mice are nocturnal and humans
are diurnal, their circadian cycle is
reversed. “We know that in humans
the repair mechanism that prevents
cancer is the opposite of what we see
in mice. From that we extrapolated
that in humans it would be the opposite. In humans (UV exposure) is
more carcinogenic in the afternoon
than in the morning,” he says.
“In humans (UV
exposure) is more
carcinogenic in the
afternoon than in the
morning.”
Aziz Sancar, M.D., Ph.D.
Chapel Hill, N.C.
Dr. Sa nc a r says hu ma ns c a n
have d i f ferent chronot y pes, or
body clocks, “but in the majority
of humans, the chronotype shifts
by a couple of hours; it’s not a big
shif t. Even within the different
chronotypes, one can say with relative confidence that in humans the
repair will be better in the morning,
whether it is at 7 o’clock, or 5 a.m.
We can say with confidence that in
all chronotypes, it will be better in
the morning.”
“In some cancer tissues the clock
isn’t functioning anymore,” he says.
“So you take this drug when repair
is at t he ma x imum in a l l ot her
tissue so t hat
you m i n i m i z e
Dr. Zachary
the side effects
while you have
the same toxic
ef fect on t he
cancer cells.”
Other studies
have demonstrated a circadian impact
on response to
blood pressure medications and
f lu v a c c i n at ion, w h ic h v a r ie d
depending upon the time of day
the drugs were administered. Dr.
Sancar says he suspects there might
be a similar response with regard to
surgical trauma and healing.
C h r i stopher Z acha r y, M .D.,
chairman of t he depar tment of
dermatology, University of California, Irvine, found the research
intriguing and the findings robust.
He says it fits with human evolution as a diurnal species that arises
with first sunlight, and with other
observed cyclical patterns such as
those of cortisol and melatonin.
But Dr. Zachary says he doubts
that the new information will influence the advice that dermatologists
g ive to pat ient s rega rd i ng su n
exposure. Rather than complicate
the message, he says, dermatologists should stick with the simple,
s t r a i g ht f o r w a r d o n e o f u s i n g
sunscreen a nd minimizing sun
exposure — regardless of the time
of day. DT
Circadian impact
T h i s i n for m at ion h a s c l i n ic a l
implications. Dr. Sancar cites the
example of cisplatin, one of the most
commonly used cancer drugs, which
damages healthy tissue as well as
the tumor. He says in treating some
cancers it is best to administer the
drug when cellular repair mechanisms are at their highest and the
healthy tissue can best repair itself.
Disclosures: The research was
conducted with grant support from
the National Institutes of Health. Drs.
Sancar and Zachary report no relevant
financial interests.
FOR THE TREATMENT OF ACNE VULGARIS
Dive in
with Atralin
®
Optimized for
efficacy with
minimal irritation
mean reduction in inflammatory lesions
• at36%12 weeks*
mean reduction in noninflammatory
• 41%
lesions at 12 weeks*
• Low irritation profile
• Moisturizing and hydrating agents
1
1
1
† 2-4
*Combined results of two 12-week, prospective, multicenter, randomized, vehicle-controlled
studies of patients with mild to moderate acne vulgaris of the face.1
†The contribution of individual components to efficacy has not been evaluated.
Indication and Important Safety Information: Atralin Gel is indicated for the
treatment of acne vulgaris. The most common adverse reaction was mild to
moderate irritation of the skin (ie, dry skin, skin burning, erythema, and exfoliative
dermatitis), which occurred during the first few weeks of treatment with Atralin
Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme
wind or cold, and harsh skincare products. Use of sunscreen products of at
least SPF 15 and protective clothing over treated areas are recommended when
exposure cannot be avoided. Atralin Gel should not be used on eczematous or
sunburned skin due to potential for severe irritation.
References: 1. Data on file, CORIA Laboratories. 2. Weindl G, Schaller M, Schäfer-Korting M, Korting HC.
Hyaluronic acid in the treatment and prevention of skin diseases: molecular, biological, pharmaceutical and
clinical aspects. Skin Pharmacol Physiol. 2004;17(5):207-213. 3. Morganti P. Skin hydration. In: Magdassi S,
Touitou E, eds. Novel Cosmetic Delivery Systems. New York, NY. Marcel Dekker, Inc; 1999:71-98.
4. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection.
Skin Therapy Lett. 2005;10(5):1-8.
AtralinGel.com
Please see brief summary of prescribing
information on next page.
© 2010 CORIA Laboratories, a division of Valeant Pharmaceuticals North America COR-137791-1210
24
Dermatology Times
|
January 2012
quick takes
◾ body Hair deters bedbugs
sheffield, england — Findings
of a recent study suggest bedbugs
BRIEF SUMMARY
(see package insert for full prescribing information)
For topical use only
INDICATIONS AND USAGE
Atralin Gel is a retinoid indicated for topical treatment of
acne vulgaris.
Important Limitations of Use
The safety and efficacy of the use of this product in the
treatment of any other disorders have not been evaluated.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Skin Irritation
The skin of certain individuals may become dry, red, or
exfoliated while using Atralin Gel. If the degree of irritation
warrants, patients should be directed to temporarily reduce
the amount or frequency of application of the medication,
discontinue use temporarily, or discontinue use altogether.
Efficacy at reduced frequencies of application has not been
established. If a reaction suggesting sensitivity occurs, use
of the medication should be discontinued. Mild to moderate
skin dryness may also be experienced; if so, use of an
appropriate moisturizer during the day may be helpful.
Tretinoin has been reported to cause severe irritation on
eczematous or sunburned skin and should be used with
caution in patients with these conditions.
Topical over-the-counter acne preparations, concomitant
topical medication, medicated cleansers, topical products
with alcohol or astringents, when used with Atralin Gel,
should be used with caution [see Drug Interactions (7)].
Ultraviolet Light and Environmental Exposure
Unprotected exposure to sunlight, including sunlamps,
should be minimized during the use of Atralin Gel. Patients
who normally experience high levels of sun exposure, and
those with inherent sensitivity to sun, should be warned
to exercise caution. Use of sunscreen products of at
least SPF 15 and protective clothing over treated areas is
recommended when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be
irritating to patients under treatment with tretinoin.
Fish Allergies
Atralin Gel contains soluble fish proteins and should be used
with caution in patients with known sensitivity or allergy
to fish. Patients who develop pruritus or urticaria should
contact their health care provider.
ADVERSE REACTIONS
Clinical Studies Experience
Because clinical trials are conducted under prescribed
conditions, adverse reaction rates observed in the clinical
trials of a drug cannot be directly compared with rates in the
clinical trials of another drug and may not reflect the rates
observed in practice.
In two randomized, controlled trials, 674 subjects received
treatment for up to 12 weeks with Atralin Gel [see Clinical
Studies (14)]. In these studies, 50% of the subjects who
were treated with Atralin Gel reported one or more adverse
reactions; 30% of the subjects reported treatment-related
adverse reactions. In the vehicle group, 29% of the 487
randomized subjects reported at least one adverse reaction;
5% of the subjects reported events that were treatmentrelated. There were no serious, treatment-related adverse
reactions reported by subjects in any of the treatment groups.
Selected adverse reactions that occurred in at least 1% of
subjects in the two studies combined, are shown in Table
1 (below). Most skin-related adverse reactions first appear
during the first two weeks of treatment with Atralin Gel, and
the incidence rate for skin-related reactions peaks around
the second and third week of treatment. In some subjects
the skin-related adverse reactions persist throughout the
treatment period.
Table 1. Number of Subjects with Selected Adverse
Reactions (Occurring in At Least 1% of Subjects)
Event
Atralin Gel
(n = 674)
Vehicle Gel
(n = 487)
Dry Skin
109 (16%)
8 (2%)
78 (12%)
7 (1%)
Peeling/Scaling/
Flaking Skin
Skin Burning
Sensation
53 (8%)
8 (2%)
Erythema
47 (7%)
1 (<1%)
Pruritus
11 (2%)
3 (1%)
Pain of Skin
7 (1%)
0 (0%)
Sunburn
7 (1%)
3 (1%)
DRUG INTERACTIONS
When treating with Atralin Gel, caution should be exercised
with the use of concomitant topical medication, medicated
or abrasive soaps and cleansers, products that have a
strong drying effect, and products with high concentrations
of alcohol, astringents, spices, or lime. Particular caution
should be exercised with the concomitant use of topical
over-the-counter acne preparations containing benzoyl
are thwarted by body hair, Medical
News Today reports.
Researchers with University
peroxide, sulfur, resorcinol, or salicylic acid. Allow the
effects of such preparations to subside before use of Atralin
Gel is begun.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C. There are no well-controlled trials
in pregnant women treated with Atralin Gel. Atralin Gel
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for
maternal and developmental toxicity in pregnant SpragueDawley rats by dermal application. The dose of 1 g/kg/day
was approximately 4 times the clinical dose assuming 100%
absorption and based on body surface area comparison.
Possible tretinoin-associated teratogenic effects
(craniofacial abnormalities [hydrocephaly], asymmetrical
thyroids, variations in ossification, and increased
supernumerary ribs) were noted in the fetuses of Atralin Gel
treated animals. These findings were not observed in control
animals. Other maternal and reproductive parameters in the
Atralin Gel treated animals were not different from control.
For purposes of comparison of the animal exposure to
human exposure, the clinical dose is defined as 2 g of Atralin
Gel applied daily to a 50-kg person.
Oral tretinoin has been shown to be teratogenic in rats,
mice, rabbits, hamsters and nonhuman primates. Tretinoin
was teratogenic in Wistar rats when given orally in doses
greater than 1 mg/kg/day (approximately 8 times the clinical
dose based on body surface area comparison). In the
cynomolgus monkey, fetal malformations were reported for
doses of 10 mg/kg/day, but none were observed at 5 mg/
kg/day (approximately 80 times the clinical dose based
on body surface area comparison), although increased
skeletal variations were observed at all doses. Dose-related
increases in embryolethality and abortion also were
reported. Similar results have also been reported in
pigtail macaques.
Topical tretinoin in a different formulation has generated
equivocal results in animal teratogenicity tests. There is
evidence for teratogenicity (shortened or kinked tail) of
topical tretinoin in Wistar rats at doses greater than 1 mg/
kg/day (approximately 8 times the clinical dose assuming
100% absorption and based on body surface area
comparison). Anomalies (humerus: short 13%, bent 6%, os
parietal incompletely ossified 14%) have also been reported
when 10 mg/kg/day (approximately 160 times the clinical
dose assuming 100% absorption and based on body surface
area comparison) was topically applied. Supernumerary
ribs have been a consistent finding in rats when dams were
treated topically or orally with retinoids.
With widespread use of any drug, a small number of birth
defect reports associated temporally with the administration
of the drug would be expected by chance alone. Cases of
temporally associated congenital malformations have been
reported with use of other topical tretinoin products. The
significance of these spontaneous reports in terms of risk to
the fetus is not known.
Nonteratogenic effects on fetuses: Oral tretinoin has been
shown to be fetotoxic in rats when administered in doses
20 times the clinical dose based on a body surface area
comparison. Topical tretinoin has been shown to be fetotoxic
in rabbits when administered in doses 8 times the clinical
dose based on a body surface area comparison.
Nursing Mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution
should be exercised when Atralin Gel is administered to a
nursing woman.
Pediatric Use
Safety and effectiveness in children below the age of 10
have not been established.
A total of 381 pediatric subjects (aged 10 to 16 years),
treated with Atralin Gel were enrolled into the two clinical
studies. Across these two studies, comparable safety
and efficacy were observed between pediatric and
adult subjects.
Geriatric Use
Safety and effectiveness in a geriatric population have
not been established. Clinical studies of Atralin Gel did not
include any subjects over age 65 to determine whether they
respond differently than younger subjects.
Marketed by:
CORIA Laboratories, a division of Valeant Pharmaceuticals
North America, Aliso Viejo, CA 92656
Manufactured by:
DPT LABORATORIES, LTD.
San Antonio, Texas 78215
Patent No.: 5,670,547
Revised: 11/2009
137623-1109
of Sheffield, England, recruited 29 healthy
participants and had each shave one arm
and leave one arm with hair. Bedbugs were
placed on the skin of both arms. Study results
demonstrated that the body hair helped the
host to detect the presence of bedbugs by
increasing the time it took for the parasite
to find a suitable site for latching on, and by
helping the host feel the presence of the bug
on the skin. The hair also acted as a barrier.
The authors suggested the results help to
explain why bedbugs and other parasites,
such as ticks and leeches, tend to seek out
less hairy body sites, such as wrists and
ankles.
The study was published in the Dec. 14
issue of the journal Biology Letters.
◾ uV rays may stop cHickenpox
London — Ultraviolet (UV) rays may
inactivate the chickenpox virus on the skin
before it can be transmitted to another
person, Medical News Today reports.
A study published in Virology Journal
and led by researchers with the University
of London suggests that the impact of UV
rays on chickenpox could explain why
the disease tends to spread less easily in
tropical climates.
The study involved analyzing evidence
from 25 studies on the prevalence of varicella-zoster virus and examining disease
patterns in temperate and tropical regions
around the globe. After ruling out other
factors, UV rays was found to be the only
variable most strongly linked to infection
patterns in each of the countries studied,
the researchers found.
◾ geL materiaL HeLps HeaL skin
baltimore — A jelly-like material has
been shown to help grow new, scar-free
tissue in skin with third-degree burns,
Medical News today reports.
Researchers with Johns Hopkins tested
a water-based, three-dimensional framework of polymers and used this “hydrogel”
to serve as a simple wound dressing
for third-degree burns. In mouse tissue
tests, the hydrogel produced “promising”
results, although it has yet to be tested in
human patients.
The hydrogel was designed to allow
tissue regeneration and blood vessel
formation to develop quickly, the study
authors noted. The study was published
online Dec. 12-16 in Early Edition of
Proceedings of the National Academy of
Sciences.
◾ patent may undercut saVings
thousand oaks, calif. — Amgen’s
recent new patent approval for its blockbuster drug Enbrel (etanercept) could
undermine savings that were projected in
the federal healthcare law, the New York
Times reports.
Enbrel, a treatment for psoriasis and
rheumatoid arthritis, was one of several
biologic drugs expected to face competition from similar medications in the coming
years, helping to save billions of dollars in the
healthcare system each year. Instead, Amgen
was granted a patent that does not expire until
2028. The drug costs about $20,000 a year. In
2010, Enbrel’s sales in the United States and
Canada totaled $3.5 billion.
Merck had announced earlier this year
that it had planned to develop a biosimilar
version of Enbrel.
◾ derm’s kiLLer gets Life term
guadeloupe — A man convicted of the
2006 killing of a Chicago dermatologist
was sentenced to life in prison during a trial
here, NBC Chicago reports.
Hans Peterson, a French and American
citizen who fled to this French West Indies
island, was found guilty of stabbing to
death 64-year-old David Cornbleet, M.D.,
a Chicago dermatologist who had treated
Mr. Peterson with Accutane (isotretinoin,
Roche; withdrawn from U.S. market in
2009). Mr. Peterson, 33, had claimed the
drug left him with sexual problems, the
Chicago Tribune reports.
Mr. Peterson, who avoided extradition
to the United States due to French law, will
be eligible for parole in 22 years. He will
serve his sentence in France.
◾ Lawsuit aLLeges censorsHip
new york — A New York dentist is being
sued by a former patient for allegedly
requiring him to sign a contract prohibiting
him from posting negative reviews about
the physician online, MSNBC.com reports.
Robert Lee, 42, accused his former
dentist, Stacy Makhnevich, of making him
sign a contract in which he promised not to
post negative reviews online, then fining him
thousands of dollars in an effort to enforce the
contract. Jeffrey Segal, M.D., a neurosurgeon
who founded Medical Justice Services, a
company that fights medical defamation for
a fee, told MSNBC it had “retired the form”
and had told its members to stop using the
contract in the future. The class-action suit
was filed in a New York federal court. DT
Getty Images/Collection/Credit
news briefs
January 2012
|
clinical dermatology
DermatologyTimes.com
28
30
25
Getting personal
Tailored woundcare therapy
grows increasingly common
Scar improvement
Fibroblast injection addresses
facial depressions left by acne
Isotretinoin insights
IBD, bone abnormalities, depression risks very small, research shows
By John Jesitus
Senior Staff Correspondent
Birmingham, Ala. — Although it’s
tough to accurately assess the associations between isotretinoin use and
inflammatory bowel disease (IBD),
bone abnormalities or depression,
research to date shows that these risks
are very small.
“The IBD issue has scared our
patients, and some physicians,” says
Julie C. Harper, M.D., clinical associate professor of dermatology at the
University of Alabama, Birmingham.
Nationally, she says, approximately
5,170 lawsuits are pending against
isotretinoin manufacturers. To date,
she adds, manufacturers have lost the
first seven such lawsuits to be tried,
to the tune of $56 million in total
payouts (aboutlawsuits.com).
IBD is a possible isotretinoin side
effect that’s been talked about since
1986 (Martin P, Manley PN, Depew
WT, Blakeman JM. Gastroenterology.
1987;93(3):606-609), Dr. Harper says.
“The potential association of isotretinoin and IBD is not a new finding,”
she says. “What’s new are the lawsuits
that have come along with it.”
Looking for a link
One of the most important studies
Isotretinoin links to depression and
IBD may be real, but incidences
are very rare, a clinician says.
regarding this link examined data
from the Food and Drug Administration’s MedWatch database, she says.
“When investigators pooled these
data together, they found 85 cases
that reported IBD in the presence of
isotretinoin use between 1997 and
2002 (Reddy D, Siegel CA, Sands
BE, Kane S. Am J Gastroenterol.
2006;101(7):1569-1573). This got
people thinking about the issue
again.”
Next, investigators in this study
used the Naranjo adverse drug reaction probability scale to attempt
to determine whether isotretinoin
caused the IBD in any of the 85
reported cases. “The Naranjo scale is
a validated scale that has been used
for other drug association studies as
well. However, it’s not perfect,” Dr.
Harper says.
Speci f ica l ly, t he sca le’s f i rst
question asks if there is conclusive
evidence supporting the association
between the drug and the adverse
event. Dr. Harper says, though, the
Top: Getty Images/PhotoAlto
Agency RF Collections/Spohn
Matthieu; Right: Getty Images/
Jamie Grill
DT Extra Foundation issues new guidelines
Pregnant and lactating women who suffer from psoriasis
are urged to use emollients and moisturizers, such as
petroleum jelly, to care for their condition, according to
new recommendations issued by the National Psoriasis
Foundation. After first trying emollients and moisturizers,
patients may also try low-to-moderate dose topical steroids, or narrowband UVB phototherapy or light therapy as
a second-line treatment. Finally, the foundation suggests
using tumor necrosis factor inhibitors with caution, and
cyclosporine in the second and third trimesters only.
Source: National Psoriasis Foundation
study was constructed in such a way
that investigators had to answer yes
to this question. This made it difficult
for investigators to assign low scores
to the probability of the isotretinoinIBD link.
“In the end, in only four cases
(5 percent) was the association found
to be highly probable,” Dr. Harper
says.
Additionally, investigators rated
58 cases (68 percent) as probable
and 23 cases (27 percent) as possible.
Moreover, in three cases, the IBD
improved when the patients involved
stopped taking isotretinoin, and it
worsened when isotretinoin treatment resumed.
“The IBD issue has
scared some patients,
and some physicians.”
Julie C. Harper, M.D.
University of Alabama, Birmingham
“At best, the study found a few
cases where it appears there’s a pretty
strong association,” Dr. Harper says.
“But it’s still very difficult to assess.
We’re talking about a drug that has
Isotretinoin see page 26
Quotable
“The treatment appears to have a
broader field effect and provides
a more global improvement.”
Girish Munavalli, M.D.
Charlotte, N.C.
On using autologous fibroblasts for acne scars
See story, page 30
26
Dermatology Times
clinical dermatology
Isotretinoin from page 25
been prescribed countless millions
of times in our country,” but it’s
produced only 85 reports linking
isotretinoin use with IBD.
Furthermore, she says, investigators examined data from HoffmanLaRoche’s pivotal clinical trials of
isotretinoin and found no de novo
cases of IBD that were not reported
to the FDA.
Additional studies
In a subsequent review, researchers
applied Hill criteria to case reports,
c a s e s e r ie s a nd c l i n ic a l t r i a l s
exploring an association between
isotretinoin and IBD. Its authors
found only 12 case reports and one
case series documenting an association between isotretinoin use
and subsequent development of IBD
(Crockett SD, Gulati A, Sandler RS,
Kappelman MD. Am J Gastroenterol. 2009;104(10):2387-2393). These
authors concluded that, “current
evidence is insufficient to confirm or
refute a causal relationship between
isotretinoin and IBD.”
Conversely, a subsequent casecontrolled study matched 8,189
patients from a large insurance
database with more than 21,000
controls. In this study, researchers
found that among the 60 patients
who had been exposed to isotretinoin,
the odds ratio for ulcerative colitis
(UC) was 4.36 (confidence interval:
1.97 to 9.66; Crockett SD, Porter CQ,
Martin CF, et al. Am J Gastroenterol.
2010;105(9):1986-1993. Epub 2010
Mar 30).
However, Dr. Harper says, “The
number of people who were exposed
to isotretinoin in the whole group
was so low — 24 in the IBD group
and 36 controls — that it’s difficult to
assess the real absolute risk of IBD in
isotretinoin users.”
Researchers found no correlation
between isotretinoin use and Crohn’s
disease, she says.
Overa l l, Dr. Har per says, “It
appears that if there is a real association between isotretinoin and IBD, it
probably happens at a rate of about
one per 10,000 patients (Margolis DJ,
Fanelli M, Hoffstad O, Lewis JD. Am
J Gastroenterol. 2010;105(12):26102616. Epub 2010 Aug 10). That’s a
number I’ve used in my clinic to put
it in perspective. I don’t believe we
know yet if this is a real risk, so we
have to educate everybody about the
symptoms that they might experience
if IBD were to develop.”
Dr. Harper says, however, that in
her 11 years of practice, “I haven’t seen
it. But if it happens at a rate of one in
10,000, many of us will practice our
whole careers and not see it. That doesn’t
mean it’s not a risk — it’s just a risk that
may happen at a very low level, probably
in people who are predisposed to IBD.”
“Depression and IBD are
common in the same
age group of people who
develop acne and are
treated with isotretinoin.
So it makes the picture a
bit confusing.”
Julie C. Harper, M.D.
University of Alabama, Birmingham
Epiphyseal closure
Additional concerns have arisen about
the possibility that isotretinoin use
causes premature epiphyseal closure,
Dr. Harper says. However, she says, “All
of the reports of this type of problem
have involved very high isotretinoin
doses given for long periods of time,
for conditions other than acne.”
For example, one review notes that
premature epiphyseal closure has been
reported in the following patients:
n a 10 1/2-year-old boy with epidermolytic hyperkeratosis after 4 1/2
years of isotretinoin at approximately
3.5 mg/kg/day;
n an 8 1/2-year-old boy with nonbullous congenital ichthyosiform erythroderma after 6.33 years of etretinate
at 0.5 to 2.5 mg/kg/day;
n a 9-year-old boy with fibrodysplasia ossificans progressiva after five
months of 4 to 5 mg/kg/day isotretinoin (DiGiovanna JJ. J Am Acad
Dermatol. 2001;45(5):S176-S182).
Accordingly, “The doses and durations that we’re using to treat adolescents with acne do not appear to be in a
range that will increase patients’ risk for
premature epiphyseal closure,” she says.
In contrast, a separate review
involving 217 patients treated at
19 different centers showed that a
single course of isotretinoin therapy
(BID for a mean of 133 days, mean
|
January 2012
daily dose of 1 mg/kg/day) had no
clinically significant impact on bone
mineral density of the hip or lumbar
spine (DiGiovanna JJ, Langman CB,
Tschen EH, et al. J Am Acad Dermatol.
2004;51(5):709-717).
Depression update
As for isotretinoin use and depression, Dr. Harper says patients still
inquire frequently about this association.
“Many dermatologists — including
myself — believe we have seen a few
cases in which isotretinoin use was
associated with the development
of depression in patients we have
treated,” she says. “I believe it’s a real
association that happens in a very
small number of people.”
However, she says, the association
has proven particularly difficult to
assess accurately.
“In some ways, it’s similar to IBD:
Depression and IBD are common in
the same age group of people who
develop acne and are treated with
isotretinoin. So it makes the picture a
bit confusing,” she says.
Perhaps the most comprehensive
analysis of the link between isotretinoin and depression comes from a
review in which researchers combed
through 214 clinical studies to find
nine that met all their study criteria,
Dr. Harper says. Three of these nine
studies compared depression among
isotretinoin users to depression among
users of oral antibiotics for acne.
However, she says, none of these
studies — or any other studies that
used standardized depression rating
scales — showed any association
between isotretinoin use and depression, suicide or psychosis (Marqueling
AL, Zane LT. Semin Cutan Med Surg.
2007;26(4):210-220).
“In fact, in one study, some evidence
showed that the depressive index score
improved over time in a group of
people with acne taking isotretinoin.
Therefore, while I believe that it may
be a real risk that we see in some
individuals, it’s very rare. And there’s
some evidence in the literature that
isotretinoin use might even improve
depression,” Dr. Harper says. DT
Disclosures: Dr. Harper has been a
consultant for and has received honoraria from Ranbaxy.
© 2011 Kao Brands Company
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Dermatology Times
clinical dermatology
|
January 2012
Clear-cut care
Rising costs of wound treatments warrant personalized approach to therapy
By Jane Schwanke
Staff Correspondent
Miami — Skin ulcers and wounds
are the most expensive diseases
of the skin in the United States,
fe e d i n g a mu l t i bi l l i on- d o l l a r
industry of woundcare systems.
But which therapies are best? Are
simpler and cheaper alternatives
an option? And which alternatives
work best with standard of care?
According to one expert, the
data is still very limited, although
many pilot studies and preliminary
research have been done. More and
more frequent ly, treatment is a
personalized approach including
standardized woundcare (negative
pressure wound therapy, or NPWT)
a nd a n a lt e r n at i ve or a dju nc t
therapy.
“We don’t have a lot of levelone ev idence
Dr. Kirsner
when it comes
to woundcare,”
says Robert
Kirsner, M.D.,
Ph.D., der matologist, Stiefel
Laboratories
profe s s or a nd
vice chairman,
depar tment of
dermatolog y and cutaneous
surgery, University of Miami Miller
School of Medicine.
Still, like so many dermatologists, Dr. Kirsner relies on theoretic and empirical data to guide
his choices about how best to treat
wounds, and to determine when
adjunct therapy is warranted.
“The prevalence and high costs
of these skin diseases combined
w it h t he ag ing popu lat ion; t he
cont i nu i ng r ise i n r isk fac tors
Costly and common, wound
treatment in the United States
would benefit from a more
personalized, customized
approach, one dermatologist says.
for wounds; and the epidemic of
diabetes in the U.S., all call for
dermatologists to be vigilant about
proper d iag nosis a nd accu rate
treatment,” he says.
“Additionally, dermatologists
ma ke more wou nds t ha n a ny
other specialty, including plastic
surgeons and general surgeons, so
understanding what’s happening
with woundcare is very important
for our specialty,” he adds.
Negative pressure
Negative pressure has been around
for about 10 years, and while it’s
an expensive t herapy, surgeons
continue to use it because it works
so well, particularly in deeper, acute
wounds, according to Dr. Kirsner.
“You can’t ask a therapy
that’s meant to be
adjunctive to replace the
standard of care. They’re
not going to work and
you’re doing a disservice
to the patient.”
Robert Kirsner, M.D., Ph.D.
University of Miami Miller School of Medicine
“It builds granulation tissue in
these deeper wounds and is very
effective,” he says. “Since it works
in those wounds, it was tried it on
chronic wounds and unfortunately,
t he d at a supp or t i ng it s u s e i n
chronic wounds is limited.”
Sti l l, NPW T is t he leading
therapy for wounds, leaving dermatologists reluctant to use other, less
costly treatments.
“This leaves a big gap and opportunities for other therapies that
might be less expensive,” he says.
“We don’t have a lot of
level-one evidence when
it comes to woundcare.”
Robert Kirsner, M.D., Ph.D.
University of Miami Miller School of Medicine
Dr. Kirsner says that “without
evidence, expensive treatments are
at risk for not being reimbursed.
Evidence and comparative effectiveness will be critical in helping
determine which therapies are best
for which patient and at what time.”
Increasingly, alternative therapie s a re bei ng employed , such
as silver dressings or laser light
therapy as an adjunct to the standard of care, he says.
Dr. Kirsner has seen improved
outcomes i n h is pat ients when
incorporating silver dressings.
“It turns out that silver works
very well in reducing the bacterial
burden in various wounds, and we
think that at some level, bacteria
play a role in inhibiting wound
healing,” he says.
“The wound bed bacteria l
burden is reduced and for wounds
w he re b a c t e r i a a re i n h i bit i n g
healing, we think that this has a
positive effect on wound healing.
Getty Images/Blend Images/ERproductions Ltd
28
January 2012
|
clinical dermatology
DermatologyTimes.com
We do have some data to support
the notion that when silver dressings are used, the wound healing
rate improves. I use it in my practice,” Dr. Kirsner explains.
Caveats
Dr. Kirsner offers some important
precautions, whichever woundcare
system is used.
“The most important thing that
dermatologists can do is understand why the wound is there —
what’s the underlying cause?” he
says.
“Once the underlying cause has
been addressed — whether it’s a
venous leg ulcer or a diabetic foot
ulcer — we can determine if there
might be a role for other options in
addition to the standard of care.
“Part and parcel with the idea of
using alternative therapies is that
they are an adjuvant to the standard
of care, not a replacement,” Dr.
Kirsner says.
“Adjuvant treatment often does
not treat the underlying problem …
and without standard care, you’re
asking adjuvant treatment to do too
much. You can’t ask a therapy that’s
meant to be adjunctive to replace
the standard of care. They’re not
going to work and you’re doing
a disser vice to the patient,” Dr.
Kirsner adds.
Increasingly,
alternative therapies are
being employed, such as
silver dressings or laser
light therapy as an adjunct
to the standard of care.
Yet to come
For now, the basic science of wound
healing continues to emerge and
dermatologists will continue to
learn more about the critical deficiencies of why wounds fail to heal,
according to Dr. Kirsner.
“We now understand that oftentimes the wounds are turned off
29
— for a variety of reasons,” he says.
“For example, maybe it’s because
stem cells are not active or available, or that growth factors are not
available or deficient in chronic
wounds.
“As we lea rn more about t he
mecha n isms by wh ich ch ron ic
wounds fa i l to hea l, we w i l l be
able to provide targets for more
advanced therapies ... therapies
that will specifically target genes or
groups of genes that will stimulate
a wound to go on and heal,” Dr.
Kirsner says.
“This will be a more personalized medicine approach to wound
healing and I expect to see this
evolve over t he nex t f ive to 10
years,” he adds. DT
Disclosures: Dr. Kirsner reports no
relevant financial interests.
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Dermatology Times
clinical dermatology
|
January 2012
Smoothing scars
Fibroblast injection improves depressed acne marks, study shows
By Cheryl Guttman Krader
Senior Staff Correspondent
Washington — Injection of autologous
cultured fibroblasts (azficel-T; Laviv,
Fibrocell Science) is safe and effective
for improving the appearance of distensible, depressed acne scars, according
to the results of a prospective, doubleblind, placebo-controlled clinical trial
reported by Girish “Gilly” Munavalli,
M.D., at the 2011 annual meeting of
the American Society for Dermatologic
Surgery.
“Injection of autologous fibroblasts
represents an exciting and promising
new paradigm,” Dr. Munavalli says.
“Not only does it
Dr. Munavalli
appear to correct
the dermal
d e fe c t u nd e rlying distensible,
depressed acne
s c a r s , but t he
treatment appears
to have a broader
field effect and
provides a more
global improvement in regional skin
contour.”
The off-label use of autologous fibroblasts was investigated in a randomized,
phase 2/3 study conducted at eight sites.
Eligible patients had bilateral facial acne
scars involving an area of at least 9 cm2
on each cheek that were moderate to
severe based on subject and investigator
ratings. The patients in the study ranged
in age from 19 to 65 years (mean 42) and
were predominantly female and white.
One cheek of each patient was
randomized to treatment with autologous fibroblasts or vehicle (cell culture
media), and the alternate treatment
was administered on the contralateral
side. Each patient received a series of
three injections at intervals of about
Autologous fibroblast injection
presents promising new treatment
paradigm for acne scarring, study
results show.
two weeks and was evaluated for safety
and scarring severity monthly until four
months after the last injection.
Ninety-nine patients were evaluated for efficacy based on a responder
endpoint for both the subjects’ and
investigators’ ratings.
At the study’s conclusion, the
responder rate was significantly higher
for the autologous fibroblast treatment compared with the control in
both the subject (43.1 vs. 18.3 percent)
and investigator assessments (58.7 vs.
42.2 percent).
The autologous fibroblast injections
were well tolerated, and there were no
serious adverse events or study withdrawals related to a treatment emergent
adverse event, says Dr. Munavalli,
medical director of Dermatology, Laser
& Vein Specialists of the Carolinas,
A patient with distensible, depressed acne scarring before (left) and three years
after three treatments with azficel-T, administered about three weeks apart.
(Photos: Gilly Munavalli, M.D.)
Study results
At one month after the last injection,
treatment with the autologous fibroblast
injection was associated with a significantly higher responder rate compared
with control in both the subject and
investigator ratings. Responder rates
for treatment with the autologous fibroblasts continued to increase throughout
follow-up and reached a plateau after
three months with the vehicle injection.
Charlotte, N.C., and clinical assistant professor of dermatology, Wake
Forest University School of Medicine,
Winston-Salem.
The process
T he autologous f ibroblasts a re
harvested by taking three 4-mm postauricular punch biopsies. The tissue
is sent overnight to the manufacturer,
where the fibroblasts are isolated,
Getty Images/the Agency Collection/knape
30
January 2012
|
clinical dermatology
DermatologyTimes.com
expanded in culture, and packaged in
vials containing 10 million to 20 million
cells/mL.
The injections are performed either
under topical anesthesia or with local
anesthesia using a ring block. The cells
are withdrawn from the manufacturer’s
vial into 0.5 mL tuberculin syringes
equipped with a 28 gauge to 30 gauge
needle and delivered into the upper
papillary dermis in a grid approach
under and around the scars, administering 0.1 mL/cm2 and a maximum a
total volume of 2 mL per session.
Dr. Munavalli says the improvement
seen with the vehicle control treatment
is not surprising, since acne scarring
also improves with skin needling and
subcision, presumably through stimulation of collagen synthesis.
The progressive improvement
during follow-up after the last fibroblast injection and the global type of
improvement achieved suggest that the
cells remain viable for some time after
injection and are continuing to produce
31
collagen, as well as perhaps also stimulating neighboring native fibroblast
activity through paracrine effects, Dr.
Munavalli says. DT
Disclosures: Dr. Munavalli is an investigator and consultant for Fibrocell. He is on
the speakers bureaus and is a consultant
for Merz and Medicis.
Assessing severity
In the clinical trial, patients rated the
severity of their scarring using a fivepoint Subject Live Acne Scarring scale
that asked them to describe how they
felt about the appearance of their cheek
(-2 = very dissatisfied, 0 = somewhat
satisfied, +2 = very satisfied). Investigators used the five-point Evaluator Live
Acne Scar Assessment (ELASAS; 0 =
clear, 4 = severe) that was developed and
validated for the study.
“Injection of autologous
fibroblasts represents an
Dermatology
is our passion.
Innovation is
our mission.
Bayer HealthCare
is our name.
exciting and promising
new paradigm.”
INTENDIS is now
Girish Munavalli, M.D.
Charlotte, N.C.
For the subject ratings, patients were
defined as responders if they achieved a
two-point improvement from baseline;
a one-point improvement was used to
define responders for the evaluators’
ratings.
“There are few validated instruments
for assessing the severity of acne scarring. The ELASAS was developed to
address this issue, and in testing it was
shown that a one-point change in score
was indicative of a clinically meaningful
change in acne scarring severity,” Dr.
Munavalli says.
Adverse e vent s i n t he st udy
were generally limited to injection
site reactions, with erythema and
swelling the only events that occurred
in 5 percent or more of patients. The
overall rate for both types of reaction was 11 to 12 percent for both
treatments, although the reactions
were mild to moderate in severity
following the fibroblast injections
and only mild after vehicle injection.
Our name may have changed,
but our principles haven’t.
Together, Intendis, a leader in
dermatologic treatments, and
Bayer HealthCare, a global
healthcare leader, are changing
the future of dermatology.
Making it easier for you to meet
the needs of patients—and
improve the quality of their lives.
A Passion for Dermatology
© 2011 Bayer HealthCare Inc. All rights reserved.
100-10-0004-11 December 2011. Printed in USA.
32
SPECIAL REPORT
Dermatology Times
37
38
|
January 2012
Point of care
Acupuncture’s effects
can improve skin conditions
Inside out
Dietary supplements effective
with personalized approach
Homeopathic option
Derm, husband create software to allow colleagues to offer alternative therapies
By Lisette Hilton
Staff Correspondent
Medina, Ohio — An Ohio dermatolo-
gist and her husband are developing a
software program that will allow
dermatologists to incorporate homeopathy as a treatment option for patients
who desire an alternative approach.
Helen M. Torok, M.D., and her
husba nd, Leonard Torok, M.D.
— who consults with his wife on
dermatologic
Dr. Torok
cases — have
found homeopathy to be effect i ve for m a ny
skin conditions,
including acne
and eczema.
Ty p i c a l l y,
doctors who
incorporate
homeopathy into a traditional practice must undergo training, study
extensively, and invest substantially
more time into patient visits. The
Toroks say they hope to at least
modify that with software that will
make the modality a viable option at
the point of care.
“What we’re trying to do is make
it practical and cost-effective for the
patient and practitioner,” says Dr.
Leonard Torok, a homeopathic physician and orthopedic surgeon who has
partnered with his wife for nearly a
decade at their Trillium Creek practice near Medina.
“We’re developing a sof tware
system where we collect information
on the patient, put it into a software
system, and the software will point
the practitioner in the direction
of which (homeopathic) remedy is
appropriate,” he says.
The use of herbal preparations
and dietary modifications can
resolve some skin conditions.
dermatologytimes.com/herbs
How homeopathy works
The principle that “like cures like”
is central to homeopathy, the Toroks
say. It means that a disease can be
cured by a substance that produces
similar symptoms in healthy people.
The Torok s say dermatolog ists
already are familiar with this concept,
as they use intense pulsed light (IPL).
“IPL is a homeopathic treatment,”
says Dr. Helen Torok, clinical assis-
Naturopathic therapies serve as
powerful adjuncts in skin cancer
treatments.
dermatologytimes.com/natural
pat hs bel ieve t hat t he sha k i ng
creates an imprint of the substance
being diluted, and this imprint can
stimulate healing, according to
Homeopathy see page 34
DT Extra White tea may reduce wrinkles
“Each patient is treated in a
unique fashion.”
Ryan Lombardo, D.A.O.M., L.Ac.
Evanston, Ill.
On treating various conditions with acupuncture
See story, page 37
White tea and other plant extracts may help fight
wrinkles and reduce the risk of cancer and rheumatoid arthritis, according to a study by investigators
with Kingston University, London. The research
team, working with British skincare company Neal’s
Yard Remedies, tested 21 plant extracts for efficiency in fighting cancer and signs of aging. White
tea, rose and witch hazel showed “considerable”
potential for these purposes, with white tea demonstrating the most marked results.
Source: Kingston University, London
Top: Getty Images/Yuri Arcurs;
Left: Getty Images/Fotosearch
Getty Images/Collection/Credit
Quotable
Dermatologist Helen Torok, M.D.,
has teamed with her homeopathic
physician husband to develop
software that helps other
practitioners offer patients
evidence-based alternative
treatment options.
tant professor of internal medicine at
Northeast Ohio Medical University,
formerly the Northeastern Ohio
Universities College of Medicine.
“Sunlight causes damage, which we
treat with intense pulses of light.”
Homeopathy attempts to spur the
body’s ability to heal itself by giving
the patient very small doses of highly
diluted substances. “Remedies” are
prepared through a standardized
process of serially diluting various
types of plant, mineral or animal
matter, alternating with vigorous
shaking (or “succussion”). Homeo-
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nationaleczema.org for more information.
34
Dermatology Times
SPECIAL REPORT
Homeopathy from page 32
the National Institutes of Health’s
National Center for Complementary
and Alternative Medicine. Most
homeopathic remedies are so dilute
that no molecules of the original
substance remain.
In the United States, remedies
are regulated by the Food and Drug
Administration in the same manner
as nonprescription, over-the-counter
drugs. “There is a branch under the
supervision of the FDA called Homeopathic Pharmacopeia Convention of
the U.S. (HPCUS), and it oversees all
the manufacturing and drug information of all the homeopathic remedies,”
Dr. Leonard Torok says.
However, because homeopathic
products contain little or no active
ingredients, they are not required to
dermatology after they launch the
program.
Dr. Leonard Torok uses some
of the homeopathic remedies in
conjunction with traditional dermatologic therapies. But many, including
the remedy for molluscum contagiosum, work alone to gently cure
the indicated skin condition, he says.
Remedies are available in several
“potencies,” graded according to the
dilution factor, including some low
potencies that are readily available
over the counter. Therapeutically, the
Toroks most often use liquid remedies
in the LM1 potency range, adjusting
the frequency as needed, he says.
Among the conditions the Toroks
treat with homeopathy:
Molluscum contagiosum. Dr.
Leonard Torok says molluscum
A 4-year-old female patient with severe eczema is shown before (left) and five months
after undergoing weekly therapy with the homeopathic remedy carcinosis, made from
extremely diluted breast cancer tissue. (Photos: Leonard Torok, M.D.)
undergo the same safety and efficacy
testing as prescription and new OTC
drugs, according to the NIH.
Homeopaths traditionally prescribe
remedies based on a thorough assessment of the patient, including a
detailed history, physical characteristics and symptoms, and current
emotional and mental states. The
treatment capabilities of homeopathy
have been documented for more than
200 years, Dr. Leonard Torok says.
Remedies for skin
The Toroks began their software
project early in 2011, but they say
it could take until beyond 2012 to
complete. So far, they have documented experiences with several
der matolog ic pat ient s a nd a re
compiling literature for the program
in six areas: molluscum contagiosum,
warts, acne, eczema, psoriasis and
contact dermatitis. They say they’ll
tackle other conditions and cosmetic
contagiosum was chosen as the
first condition in the pilot program
because traditional medical treatments are not satisfactory.
“For children, the treatments
can be painful or scarring,” he says.
“Using homeopathic remedies we’ve
in some patients been able to resolve
their molluscum in a relatively short
period of time without any problems.”
For cases of molluscum contagiosum, he turns to two remedies:
silica, made from beach sand, and
calcium carbonate. Patients take
one or the other remedy in a f luid
dropper, putting a drop in their
mouths, generally twice a day.
Warts. There are two common
homeopathic remedies for warts,
according to Dr. Leonard Torok:
nitric acid and thuja, which is made
from coniferous trees.
“We probably have used thuja
here for six to eight years and have
got ten about 25 percent of t he
wart patients to resolve,” he says.
|
January 2012
“To up our success, we’ve come up
with algorithms the software will
work through to try to increase the
specificity, (to determine different
remedies) based on the symptoms of
the warts and their location.”
Acne. The doctors say they started
the acne program pilot with two of
the practice’s most difficult cases, and
those patients are responding.
“One remedy is based on t he
mineral sulphur. The other is medorrhinum,” Dr. Leonard Torok says.
All the homeopathic remedies are
taken orally and usually once a day,
he says.
Unlike allopathic medicine, which
relies on physical or chemical forms
of medicine with active ingredients,
homeopathy is an energetic form of
information to the body, the Toroks
say. So, unlike drugs, homeopathic
remedies do not cause side effects,
because the body doesn’t use information in a negative way.
Eczema. Dr. Leonard Torok is
documenting a case of severe eczema
in a 4-year-old girl he has been treating
for about four years. The child, he says,
has never been on standard dermatologic treatments for her disease, and
she has been plagued by severe, uncontrolled eczema almost from birth.
“She’s just about normal. She’s now
able to eat food that she wasn’t able
to eat before,” he says. “She has had
about six or eight different remedies
over the years. Interestingly, the
remedy that worked best for her was
carcinosis. That’s a remedy made
from breast cancer. She takes a little
drop of the liquid
Dr. Torok
carcinosis in the
mout h, maybe
about a dose
every six weeks.”
Contact
dermatitis.
Dr. L e ona rd
Torok has long
prescribed rhus
toxicodendron,
the botanical name for the poison ivy
plant, to treat poison ivy.
Dr. Helen Torok says that treating
poison ivy patients homeopathically
has been a rewarding experience. Rather
than treating an outbreak, the Toroks
focus on preventing outbreaks using
homeopathy. She says this is especially
Homeopathy see page 40
January 2012
|
SPECIAL REPORT
DermatologyTimes.com
Pinpoint care
Effects of acupuncture beneficial in treating certain dermatologic conditions
By Lisa B. Samalonis
Staff Correspondent
Evanston, Ill. — Several common
dermatologic conditions — including
acne and psoriasis — can be effectively treated with acupuncture and
Chinese herbal medicine, according
to Ryan Lombardo, D.A.O.M., L.Ac.,
A.B.A.A.H.P., of Evanston, Ill., doctor
of acupuncture and Oriental medicine.
“I have successfully treated acne,
atopic dermatitis/eczema and psoriasis, as well as pruritis, shingles (pain
relief) and facial
skin rejuvenation
Dr. Lombardo
with a combination of acupuncture and herbal
medicine,” says
Dr. Lombardo,
who is a licensed
acupu nc t u r ist
and is certified
by the American
Board of AntiAging Health Practitioners.
Acupuncture
When patients present with a specific
skin condition to an Oriental medicine clinic, the practitioner will assess
the condition as it relates to disease
“patterns” as defined by Oriental
medicine.
For instance, acne may be a result of
patterns known as “toxic heat,” “damp
heat,” or “wind heat,” or some combination of these factors. The meridians
— energetic channels in the body that
correspond to organs and their function — affected typically include the
lung, stomach and spleen.
“Because there are numerous
potential combinations of presenting
patterns, each patient is treated in a
unique fashion. Therefore, clinical
With a personalized approach,
clinicians may find acupuncture’s
anti-inflammatory effects helpful
in treating certain skin conditions.
trial investigators struggle when
creating standardized protocols that
would replicate clinical experience.
“The recent push for evidencebased Oriental medicine is certainly
exciting for those of us interested in
research; however, funding is hard
to come by outside of the NIH’s
(Nationa l Institutes of Hea lt h)
NCCA M depar tment (Nationa l
Center for Complementary and Alternative Medicine),” he says, noting that
the majority of recent clinical trial
research in Oriental medicine comes
from China, Taiwan, Japan and Korea.
Acupoints
Acupuncture points are chosen to
address the presenting Oriental
medicine “pattern.” As such, Oriental
medicine providers are trained to assess
patterns and prescribe acupuncture,
herbal medicine, diet therapy and
lifestyle counseling to address the
presenting pattern, Dr. Lombardo says.
“As the pattern improves, so do
the presenting diseases as defined
by Western medicine. Specific point
prescriptions vary based on the
presenting pattern,” he says. “Certain
points are said to ‘drain dampness,’
‘cool the blood,’ and ‘disperse wind,’
all of which have a corresponding
physiologic response that aids the
body in healing certain conditions.”
Placement of the points varies
depending on the individual. Points
can be found on the ears, face, arms,
legs, hands, feet, torso and back.
Needles are inserted and either manually manipulated or attached to an
electroacupunture device (e-stim) for
approximately 15 to 30 minutes.
“Typically, I see patients with skin
conditions twice per week for four
to six weeks, and then re-evaluate
to decide on continuing care. Best
results have included additional
“The recent push for
evidence-based Oriental
medicine is certainly
exciting for those of us
interested in research;
however, funding is hard
to come by.”
Ryan Lombardo, D.A.O.M., L.Ac.
Evanston, Ill.
therapy such as herbal medicine and
dietary changes,” he says.
Dr. Lombardo says it appears
evident that acupuncture’s antiinflammatory effect is of great benefit
in treating dermatologic conditions.
“Also, in my experience, the reduction of stress related to acupuncture
care significantly reduces the severity
and frequency of skin conditions’
presenting symptoms,” he says.
Studies also show the benefits of
acupuncture on heart rate variability,
digestion, blood pressure, sleep, the
autonomic nervous system, sympathetic nerves and parasympathetic
activities. “All of which have an impact
on skin conditions,” Dr. Lombardo says.
Acupuncture see page 41
37
38
Dermatology Times
SPECIAL REPORT
|
January 2012
Working from within
Selected with care, dietary supplements can improve some skin conditions
By Jane Schwanke
Staff Correspondent
Miami — Dietary supplements have
garnered a variety of coverage in
the news lately, some positive and
some otherwise.
But according to one dermatologist, the media excitement over
supplements is a big reason why
dermatologists need to learn about
naturopathic therapies so they can
give accurate advice to their patients.
“I am a big fan of dietary supplements,” says Leslie Baumann, M.D.,
a dermatologist in Miami. “They’re
not harmful and many of them may
be helpful … I often recommend
them to my patients.”
D r. B a u m a n n k n o w s f i r s thand that
Dr. Baumann
dietary supplements are a hot
topic among
consumers. She
sees myriad
comments
a nd quest ions
from v isitors
who post on her
website, w w w.
sk i nt y pesolut ions.com, ask i ng
about supplements.
Where to begin?
To determine which dietary supplements her patients might benefit
from, Dr. Baumann uses a simple,
patient-focused approach. She gives
them a brief quiz to find out their
skin type and skin problems. Then
she provides a tailor-made menu of
dietary supplements based on the
information she gathered.
“For example, if the patient has a
lot of redness and inf lammation in
their skin, I’ll put them on omega
Dietary supplements are heating
up in the news lately, but patients
and physicians can get confused
about which ones are effective and
which ones should be avoided.
3 fatty acids,” Dr. Baumann says.
“If they have hair loss or thinning
hair, I’ll add Viviscal, which is a
marine extract. If they get a lot of
sun exposure, I’ll put them on the
SunPill (XenaCare) that contains a
fern extract and antioxidants. All of
these are in addition to their topical
routine.”
Dr. Bau ma n n says she of ten
s u g g e s t s s u p p l e m e nt s f o r h e r
patients to reduce their risks for
cer ta in diseases, a lt hough t his
is not proven. Typically, supplement s a re most of ten g iven to
to alleviate these symptoms, Dr.
Baumann says.
For patients with ver y dr y or
wrinkled skin, glucosamine supplements may help the body produce
hyaluronic acid, which is important
for skin hydration. Wrinkled skin
may also be improved with vitamin
C supplements because collagen
needs ascorbic acid to be formed,
she says.
I n cel l c u lt u res , add it ion of
v itamin C causes f ibroblasts to
increase collagen production. Dr.
Baumann says she believes vitamin
C is more efficiently provided to the
skin as a supplement rather than as
a topical ingredient because ascorbic
acid needs a low pH to be absorbed.
Oftentimes, Dr. Baumann says
she w i l l prescribe supplements
in combination with a treatment
regimen, she says. For example, a
“The biggest change that we’re seeing now is that as
new products hit the market, consumers don’t know
who to believe or which supplements are good.”
Leslie Baumann, M.D.
Miami
patients with redness and flushing,
melasma and sun-damaged skin,
as well as a putative skin cancer
preventive.
P a t i e nt s u s i n g c h o l e s t e r o l lowering drugs, for instance, may
be at a n i ncreased r isk of sk i n
cancer because the medication can
lower coenzy me Q10 levels and
this may play a role in the disease.
Lower coenzyme Q10 levels can
also make patients feel tired and
give them muscle cramps. Coenzyme Q10 supplements can help
patient with melasma might receive
a topical lightening cream and a
sunscreen to treat the condition,
combined with an oral antioxidant
such as vitamin C or the SunPill.
Media hype
Unfortunately, a lot of marketing
hy pe is happening now and it’s
starting to get confusing, according
to Dr. Baumann.
“For example, expensive antiaging supplements are being introduced by major companies, but
January 2012
|
SPECIAL REPORT
DermatologyTimes.com
people can just go to their local drugstore and get products a lot cheaper,”
she says. “I think the biggest change
that we’re seeing now is that as new
products hit the market, consumers
don’t know who to believe or which
supplements are good.”
That’s why dermatologists need
to be informed. A good place to
start is the library section on Dr.
Baumann’s educational website,
w w w. s k i n t y p e s o l u t i o n s . c o m ,
which includes everything she has
written about supplements over
the past 10 years. The site includes
i nfor mat ion about supplement
ingredients and benefits, as well as
her personal critiques of products
such as green tea, coffeeberry and
beta-carotene.
long-term studies, so far the data
has not revealed much, according
to Dr. Baumann.
“For now, t here are no good,
long-term studies that tell us if all
of these supplements really work or
not, but there is some basic science
that suggests they do work,” she
says. “For now, we just don’t know
39
enough. I would call myself optimistic rather than convinced, at
this point.” DT
Disclosures: Dr. Baumann reports no
relevant financial interests.
A clear message for external genital
and perianal warts (EGW)...
Potential dangers
Although the majority of dietary
supplements are safe as prescribed,
t here a re some t hat ca n pose a
danger in the wrong dose or in
certain patients.
“There are some dietary supplements that I avoid using with my
patients,” Dr. Baumann says. “I
don’t prescribe iron unless a patient
is anemic, because iron can cause
free radicals which lead to aging.
A lso, v ita mins B6 a nd B12 ca n
cause acne,” she says.
She cautions dermatologists on
using the fat soluble vitamins, A,
D, E and K, because of the overdose
factor — too much can build up in
the body and reach toxic levels.
Still, Dr. Baumann encourages
dermatologists to consider incorporating dietary supplements into
their practice.
“I think all dermatologists should
consider them for their patients,” she
says. “It’s hard to find a great brand
— I’ve looked at a lot of them and the
brand I like is Standard Process, sold
at Whole Foods or online. It’s a good
brand and a good company, and they
make great supplements.”
Dr. Bauma nn says clinicia ns
should remember that supplements
are not controlled by the government, so they need to take care when
recommending a brand to patients.
VEREGEN® Delivers Complete
Clearance With Low Recurrence
 Demonstrated complete clearance in 53.6% of
all patients studied1
 Only 6.8% rate of recurrence among patients with
complete clearance 12 weeks posttreatment1
 Proven effective in clearing both baseline and newly
emerging EGW in male and female patients1
The FIRST
VEREGEN
BOTANICAL DRUG
®
approved for prescription
use in the United States2
(sinecatechins) Ointment,15%
Get out and stay out.
VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in
immunocompetent patients 18 years and older.
Important Selected Safety Information
VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral
disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Avoid exposure of
VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety
and efficacy of VEREGEN® have not been established in immunosuppressed or pediatric patients, or pregnant women,
or for the treatment of external genital and perianal warts beyond 16 weeks or for multiple treatment courses.
The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema,
pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and rash vesicular.
References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2008]. Melville, NY: PharmaDerm, a division of Nycomed US Inc. 2. Data on file, PharmaDerm.
Please see adjacent page for Brief Summary of full Prescribing Information.
Long-term studies
While the National Institutes of
Hea lt h is current ly conducting
VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany.
©2010 PharmaDerm, a division of Nycomed US Inc. Melville, NY 11747. All rights reserved. 98NVE400910
40
Dermatology Times
SPECIAL REPORT
Homeopathy from page 34
helpful for patients such as landscapers
who tend to suffer from poison ivy.
“We give patients the pellets and they
take them (under the tongue) the first
day of the month. That gives them the
immunity (for that month),” she says.
“If they do break out, then we increase
the dose and have them take a couple of
pellets every day — maybe two or three
times a day — until symptoms resolve.”
The symptoms with the preventive approach tend not to be as bad,
she says. The homeopathic approach
also means patients can avoid the
use of and side effects from prednisone and topical steroids.
Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com
Veregen
USE IN SPECIFIC POPULATIONS
(sinecatechins)
Pregnancy Category C: There are no adequate and well controlled studies in pregnant
women. Veregen® should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
®
Pregnancy
Ointment, 15%
Rx Only
Nursing Mothers
It is not known whether topically applied Veregen® is excreted in breast milk.
For Topical Dermatologic Use Only
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
INDICATIONS AND USAGE
Veregen® is indicated for the topical treatment of external genital and perianal warts
(Condylomata acuminata) in immunocompetent patients 18 years and older.
The safety and effectiveness of Veregen® have not been established for treatment
beyond 16-weeks or for multiple treatment courses.
The safety and effectiveness of Veregen® in immunosuppressed patients have not
been established.
CONTRAINDICATIONS
None
CLINICAL STUDIES
Two randomized, double-blind, vehicle-controlled studies were performed to
investigate the safety and efficacy of Veregen® in the treatment of
immunocompetent patients 18 years of age and older with external genital
and perianal warts. The subjects applied the ointment 3 times daily for up to
16 weeks or until complete clearance of all warts (baseline and new warts
occurring during treatment).
Over both studies the median baseline wart area was 51 mm2 (range 12 to
585 mm2), and the median baseline number of warts was 6 (range 2 to 30).
The primary efficacy outcome measure was the response rate defined as the
proportion of patients with complete clinical (visual) clearance of all external
genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2
for all randomized subjects dispensed medication.
Table 1: Efficacy by Region
Complete Clearance
All Countries (includes the United States)
Veregen® 15% (N = 397)
213 (53.6%)
Vehicle (N = 207)
73 (35.3%)
United States
Veregen® 15% (N = 21)
5 (23.8%)
Vehicle (N = 9)
0 (0.0%)
Table 2: Efficacy by Gender
Complete Clearance
Males
Veregen® 15% (N = 205)
97 (47.3%)
Vehicle (N = 118)
34 (28.8%)
Females
Veregen® 15% (N = 192)
116 (60.4%)
Vehicle (N = 89)
39 (43.8%)
Median time to complete wart clearance was 16 weeks and 10 weeks, respectively,
in the two phase 3 clinical trials.
The rate of recurrence of external genital and perianal warts 12 weeks after
completion of treatment in subjects with complete clearance is 6.8% (14/206) for
those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.
WARNINGS AND PRECAUTIONS
Veregen® has not been evaluated for the treatment of urethral, intra-vaginal,
cervical, rectal, or intra-anal human papilloma viral disease and should not be used
for the treatment of these conditions.
Use of Veregen® on open wounds should be avoided.
Patients should be advised to avoid exposure of the genital and perianal area to sun/
UV-light as Veregen® has not been tested under these circumstances.
Seven patients (1.4%), older than 65 years of age were treated with Veregen® in
clinical studies. This, however, is an insufficient number of subjects to determine
whether they respond differently from younger subjects.
ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of another drug and may not reflect the rates observed
in practice.
In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per
day topical application for the treatment of external genital and perianal warts for up
to 16 weeks.
Serious local adverse events of pain and inflammation were reported in two subjects
(0.5%), both women.
In clinical trials, the incidence of patients with local adverse events leading to
discontinuation or dose interruption (reduction) was 5% (19/397). These included
the following events: application site reactions (local pain, erythema, vesicles,
skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis,
dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin
ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.
Local and regional reactions (including adenopathy) occurring at >1% in the groups
treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema
(70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%),
erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash
vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%),
discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%),
irritation (1%, 0%), and rash (1%, 0%).
A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate
or a severe reaction that was considered probably related to the drug, of which 120
(30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of
women and in 24% (49/205) of men. The percentage of subjects with at least one
severe, related adverse event was 26% (86/328) for subjects with genital warts only,
42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of
subjects with perianal warts only.
Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with
Veregen® and in 1% (1/99) in vehicle.
The maximum mean severity of erythema, erosion, edema, and induration was
observed by week 2 of treatment.
Less common local adverse events included urethritis, perianal infection,
pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and
discoloration. Other less common adverse events included cervical dysplasia, pelvic
pain, cutaneous facial rash, and staphylococcemia.
In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity
(type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.
DOSAGE AND ADMINISTRATION
Veregen® is to be applied three times per day to all external genital and perianal warts.
Treatment with Veregen® should be continued until complete clearance of all warts,
however no longer than 16 weeks.
HOW SUPPLIED/STORAGE AND HANDLING
Veregen® is a brown ointment and is supplied in an aluminum tube containing
15 grams (NDC # 10337-450-15) of ointment per tube.
Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F).
After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.
Manufactured by:
C.P.M. Contract Pharma GmbH & Co. KG
Frühlingstrasse 7
D-83620 Feldkirchen-Westerham
Germany
U.S. Patent Nos. 5795911 and 5968973
Manufactured for:
Melville, NY 11747 USA
98NVE390210
|
January 2012
Psoriasis. The doctors have yet
to use homeopathy on a psoriasis
patient, according to Dr. Leonard
Torok, but they plan to offer it to all
their psoriasis patients at the start of
2012. Patients can then elect whether
to use homeopathy along with their
standard dermatologic care.
Integration pros, cons
According to Dr. Leonard Torok,
there are two disadvantages and three
advantages to integrating homeopathic principles into a traditional
dermatology practice.
“The two disadvantages are (No. 1):
the time involved. You need a much
longer history,” he says. “The other
disadvantage is that most dermatologists don’t have any training in
homeopathic medicine — how to pick
the remedy and then the potency,” he
says. “One advantage that we’re seeing
is that homeopathy probably offers
people a curative response; (whereas),
in the traditional dermatology system,
we’re only managing or controlling
their disease.”
A second advantage is that there
are no side effects in homeopathic
medicine, Dr. Leonard Torok says. Dr.
Helen Torok says that’s an important
consideration in a specialty that generally treats chronic conditions with
long-term use of medication, including
biologics for psoriasis, antibiotics for
acne and steroids for eczema.
A third advantage: Homeopathic
remedies are inexpensive for patients.
“The average prescription …
costs about $20 and lasts a couple of
months,” Dr. Leonard Torok says.
He s ay s h e e x p e c t s a b o u t a
70 percent success rate treating
dermatologic patients in the practice
with homeopathic remedies.
“I think the long-term goal is to
make dermatologists aware that
people with chronic diseases actually
can be cured and not just managed,”
he says. “That’s a high standard to be
shooting for, but I think we have a very
good likelihood of achieving that.”
Editor’s Note: Obtain additional
information about homeopathic
dermatology from Dr. Leonard Torok
by visiting dermatologytimes.com/
homeopathic. DT
Disclosures: The Toroks report no
relevant financial interests.
January 2012
|
SPECIAL REPORT
DermatologyTimes.com
Acupuncture from page 37
Recent research
A lter nat ive t her apie s , such a s
acupuncture, are often valued for
their effect and not necessarily for
their mechanism of action or their
outcomes of research studies as with
Western medicine.
“ T here a re ver y fe w s t ud ie s
per for med on acupu nc t u re for
dermatologic conditions that would
be considered satisfactorily performed
by Western medical standards,”
Dr. Lombardo says. “Traditionally,
acupuncture is not a protocol-based
standardized therapy. Instead, it is
very patient-centered, or individualized, care. This generally presents a
problem in clinical research for those
looking for evidence-based approaches
to acupuncture point prescriptions.”
However, there are more studies
on Chinese herbal medicine formulas
and related skin conditions because
these can easily mimic clinical trials
designed for drug therapy.
Several recent studies of note highlight the effects of Chinese herbal
medicine and acupuncture on skin
conditions. For example, two studies
demonstrated that acupuncture and
moxibustion — the application of
heat resulting from the burning of a
small bundle of tightly bound herbs,
or moxa, to targeted acupoints —
were effective combined therapy for
treating acne1 and psoriasis2.
In addition, patients with atopic
In acupuncture, needles are inserted into
the skin and are manually manipulated
or are attached to an electroacupunture
device for 15 to 30 minutes. (Photo: Ryan
Lombardo, D.A.O.M., L.Ac.)
dermatitis increasingly use complementary medicine. Salameh et al
showed that the combination of
acupuncture and Chinese herbal
medicine have a beneficial effect on
patients with atopic dermatitis and
may offer better results than Chinese
herbal medicine alone3.
Hon et al concluded that traditional
Chinese herbal medicine (TCHM)
is effective as a treatment for atopic
dermatitis (AD)4. The study used a
twice-daily concoction of an ancestral
formula containing five herbs and
found that the TCHM concoction is
efficacious in improving quality of
life and reducing topical corticosteroid use in children with moderateto-severe AD. The formulation was
palatable and well tolerated.
“People often try acupuncture as a
first resort — to avoid typical medical
therapies — or a last resort when
nothing has worked,” Dr. Lombardo
says. He adds that the end result
and relief some patients find with
acupuncture and herbal medicine,
combined with lifestyle changes, are
often beneficial, especially for those
who feel they have tried traditional
medical therapy with little success.
NCCAOM.org is the national certifying agency and has more information on Oriental medicine education
and board certification in the United
States. DT
Disclosures: Dr. Lombardo reports no
relevant financial interests.
References:
1 Li B, Chai H, Du YH, et al. Zhongguo
Zhen Jiu. 2009;29(3):247-251.
2 Wu JP, Gu SZ. Zhen Ci Yan Jiu.
2011;36(1):62-65.
3 Salameh F, Perla D, Solomon M,
et al. J Altern Complement Med.
2008;14(8):1043-1048.
4 Hon KL, Leung TF, Ng PC, et al. Br J
Dermatol. 2007;157(2):357-363. Epub
2007 May 14.
Conditions for acupuncture
The following are conditions that
are recommended by the World
Health Organization (WHO) for
treatment with acupuncture:
Respiratory diseases:
n Acute sinusitis
n Acute rhinitis
n Common cold
n Acute tonsillitis
Bronchopulmonary diseases:
n Acute bronchitis
n Bronchial asthma
Eye disorders:
n Acute conjunctivitis
n Cataract (without complications)
n Myopia
n Central retinitis
Disorders of the mouth cavity:
n Toothache
n Pain after tooth extraction
n Gingivitis
n Pharyngitis
Orthopedic disorders:
n Periarthritis humeroscapularis
n Tennis elbow
n Sciatica
n Low back pain
n Rheumatoid arthritis
Gastrointestinal disorders:
n Spasm of the esophagus and cardia
n Hiccups
n Gastroptosis
n Acute and chronic gastritis
n Gastric hyperacidity
n Chronic duodenal ulcer
n Acute and chronic colitis
n Acute bacterial dysentery
n Constipation
n Diarrhea
n Paralytic ileus
Neurologic disorders:
n Headache
n Migraine
n Trigeminal neuralgia
n Facial paralysis
n Paralysis after apoplectic fit
n Peripheral neuropathy
n Paralysis caused by poliomyelitis
n Meniere disease
n Neurogenic bladder dysfunction
n Nocturnal enuresis
n Intercostal neuralgia
41
42
cosmetic dermatology
Dermatology Times
cosmetic conundrums
44
Zoe Diana Draelos,
M.D., is a Dermatology
Times editorial adviser
and consulting professor
of dermatology, Duke
University School of
Medicine, Durham,
N.C. Questions may be
submitted via e-mail to
zdraelos@northstate.net.
|
January 2012
Flexible tool
Alexandrite laser applicable
for variety of skin conditions
Topicals and toxicity
Examining the safety of sunscreens, nail polish, other cosmetics
This is a challenging
question, and the
answer is both “yes”
and “no.” Sunscreens are carefully studied for
their safety by hazard identification, risk characterization and dose-response assessment.
Applying the product every two hours to the
equivalent of 64,000 cm2 over one day of UV
exposure is how sunscreen risk assessment is
performed. The application of 2 mg/cm2 every
two hours is about one bottle of sunscreen
daily. This is the application amount required
to demonstrate safety. Since sunscreens are
over-the-counter (OTC) drugs, they are carefully
regulated for safety by the government.
It may surprise many consumers that the
preservatives used in sunscreens are more
problematic than the filters themselves. Most
preservatives are antimicrobial and as such
possess some intrinsic toxicities. All products,
including sunscreens, possess some risk. To this
end, sunscreens should not be eaten.
Children who lick their hands and bodies
probably should wear clothing instead of
wearing sunscreen. The use of moisturizers containing sunscreens or sunscreens
themselves should be avoided at nighttime,
minimizing unnecessary sunscreen exposure.
Sunscreens should be used sparingly and carefully, and only when required. Remember that
they are OTC drugs, and this regulatory classifi-
Quotable
“The long-pulsed alexandrite
laser can be effective for
permanent hair removal.”
Joely Kaufman, M.D.
University of Miami Miller School of Medicine
On one of a variety of uses for alexandrite lasers
See story, page 44
cation is deemed necessary by the government
for the protection of the public.
QA
Are nail polishes toxic?
The question of nail
polish toxicities is
another challenging
question that nicely ties into our prior discussion
of sunscreen safety. Obviously, nail polishes are
not intended for oral ingestion in a liquid form
or in dried form as nail polish is bitten from the
nails. Nail polishes contain an ingredient known
as a phthalate. Phthalates have been linked to
certain forms of cancer in rodents. Based on this
information, California made a law stating that
no phthalates could be present in products sold
in the state, forcing nail polish manufacturers to
scramble for another ingredient. Phthalates are
used in sunscreen products and other skincare
formulations.
There appears to be a trend in the cosmetics
industry to market based on the absence of
certain ingredients, rather than marketing
based on the presence of certain ingredients.
For example, Vitamin A & D Ointment (Fougera
Pharmaceuticals) was extremely popular with
consumers because it contained vitamins;
however, no mention was made of the effect of
the vitamins on the skin. Products can now be
found that claim to contain no sulfates. This is
in reference to sodium lauryl sulfate, a common
surfactant detergent found in many liquid
cleansers and shampoos. Sulfate-free products
are thought to be less “harsh” on the hair and
therefore more gentle.
Q
What is the global harmonization of cosmetic ingredients?
A
Allowing commerce
to proceed seamlessly across
national boundaries has become important in
the cosmetics industry, where many companies
are multinational. To make product development
and packaging universal, cosmetic companies
must be sure that the ingredients and packaging
are approved for use in all countries.
For example, there are substances that
can be used in the United States and not in
China. Even within the United States, there are
substances that can be used in North Carolina
and not in California. This creates challenges
because it is not cost-effective to make products for sale in one locale that cannot be sold in
another.
The uniformity of regulations in the
cosmetics industry is known as “global harmonization.” You may not have heard about it to
date, but you will eventually see some labeling
on products to indicate that the products meet
global standards. DT
DT Extra Method predicts follicle activity
A cellular automation model can describe the population behavior of hair follicles, according to research
reported in Science. Investigators with University of
Southern California and Oxford University used the
model to determine that human hair follicles rely on
intrinsic growth-promoting signals. Life stages can
trigger a collective regeneration wave, activating hair
stem cells by the thousands. In other stages, inhibitors
in the macroenvironment cause individual follicles to
remain locked in telogen.
Source: Medical News Today
Getty Images/Digital Vision/
Flying Colours Ltd
Getty Images/Collection/Credit
QA
Are sunscreens safe?
44
Dermatology Times
cosmetic dermatology
|
January 2012
light on lasers
Joely Kaufman, M.D.,
is assistant professor of
clinical dermatology at
the University of Miami
Miller School of Medicine
and director of lasers for
the University of Miami
Cosmetic Group.
Jeremy Green, M.D.,
is a board-certified
dermatologist in private
practice in Coral Gables,
Fla., and is a voluntary
instructor at the
University of Miami
department of
dermatology &
cutaneous surgery.
Nazanin Saedi, M.D.,
is a board-certified
dermatologist and
laser surgery fellow at
SkinCare Physicians,
Chestnut Hill, Mass.
The right light
Alexandrite laser a versatile tool for a variety of dermatologic applications
F
irst mined from the Ural Mountains in Russia and purportedly
named for the young Czar
Alexander II, alexandrite is a
chameleon-like gemstone that changes
color depending on ambient light. Daylight
produces an emerald green hue, while
incandescent light generates a raspberryred shade.
Like the stone that sits at its core, the
alexandrite laser is a versatile instrument
that has many applications in dermatology.
Jewelers have used the gemstone for more
than a century, but it was not until the 1990s
that it was used for medical conditions.
In 1997, the Food and Drug Administration approved the 755 nm alexandrite laser
for hair removal. The 755 nm wavelength
falls at the very edge of the near infrared
spectrum, with a preferential absorption
by melanin over hemoglobin. Due to its
depth of penetration and its affinity for
melanin, lasers utilizing this crystal are
among the most widely used.
Tattoo removal
Although the quality-switched ruby laser
(694 nm) was first used to treat tattoos, the
Q-switched alexandrite 755 nm laser is
similarly absorbed by tattoo pigment and
can be used to treat dark-colored body
art. The 755 nm wavelength is less wellabsorbed by melanin compared to the
694 nm, but the longer wavelength penetrates more deeply into the skin, so there is
less risk of post-procedure hypopigmentation (Leuenberger ML, Mulas MW, Hata
TR, et al. Dermatol Surg. 1999;25(1):10-14).
Utilizing the principle of selective
photothermolysis, the pulse duration of
the Q-switched alexandrite laser is 50
to 100 nanoseconds, which allows the
laser energy to be confined to the tattoo
particle (approximately 0.1 micrometer)
more effectively than a longer-pulsed
laser. Immediately after treatment, graywhitening of the skin occurs, followed
by erythema and edema. The reaction
is color-dependent, with darker colors
producing more whitening than lighter
colors. Q-switched alexandrite lasers
perform exceptionally well when removing
black, blue and green tattoos.
Like the stone that sits at
its core, the alexandrite
laser is a versatile
instrument that has
many applications in
dermatology.
Hair removal
The long-pulsed alexandrite laser can be
effective for permanent hair removal. The
typical settings employed include pulse
durations of 2 to 20 milliseconds and
fluences of 10 to 40 J/cm2. All hair-removal
procedures are performed using cooling
to protect the epidermis while heating the
hair shaft and surrounding follicular structure. It is effective for treating dark hair
safely in patients of Fitzpatrick types I – III,
and perhaps light-colored type IV skin.
Some studies have shown that this
laser can be used safely in darker skin
types, including Fitzpatrick types IV-VI
(Garcia C, Alamoudi H, Nakib M, et al.
Dermatol Surg. 2000;26(2):130-134). As
with other hair-removal lasers the treatment endpoint is perifollicular erythema.
Extreme caution is recommended in
tanned patients, as melanin in the skin
can act as a competing chromophore,
resulting in hypopigmentation or scarring.
Pigmented lesions
The Q-switched and long-pulsed
alexandrite lasers can treat a variety of
pigmented lesions effectively:
n Lentigines can be treated with the
Q-switched alexandrite laser in most skin
types. The target melanosomes are 0.5
to 1.0 micrometers, with a thermal relaxation time of approximately 250 to 500
nanoseconds. Therefore, the Q-switched
version of the alexandrite laser is most
appropriate for selective photothermolysis. In Fitzpatrick types III and IV,
lower fluences should be employed to
diminish the risk of post-inflammatory
hyperpigmentation (Wang CC, Chen
CK. J Dermatol Treat. Epub ahead of
print, 14 July 2011). We recommend
treating patients darker than this with
Q-switched 1,064 nm Nd:YAG lasers. The
endpoint is similar to that seen in laser
tattoo removal; immediate whitening that
results from rapid heating of the target
chromophore and subsequent gas
formation. The lentigines will typically
darken over five to seven days and then
fade away. An absolute contraindication
to treatment with any Q-switched laser
wavelength is a history of gold therapy,
as this can result in laser-induced chrysiasis.
n Café au lait macules (CALMs) can
also be successfully treated with the
Q-switched alexandrite laser. Wang et
al treated 48 Chinese patients (Wang Y,
Qian H, Lu Z. J Dermatolog Treat. Epub
ahead of print, 31 July 2011) and reported
relatively high efficacy in removing
CALMs, as 26 patients (51.4 percent)
had good to excellent responses after an
average of 3.2 treatments and with a low
rate of recurrence (10.4 percent).
n Becker’s nevus can be treated by
using the long-pulsed alexandrite
laser (Choi JE, Kim JW, Seo SH, et al.
Dermatol Surg. 2009;35(7):1105-1108).
The investigators reported successful
treatment with fluences of 20 to 25 J/cm2,
3 ms pulse duration, and spot sizes of
15 to 18 mm. Becker’s nevi are difficult
to treat because the pigment originates
January 2012
|
cosmetic dermatology
DermatologyTimes.com
deep in the skin within the hair follicle,
but the longer pulse duration allows for
adequate targeting and treatment of the
chromophore. Many times, treatment of
the dark hair within the Becker’s nevus
using a long-pulsed Alexandrite laser
results in an acceptable cosmetic result
without even treating the pigmentation.
n Nevus of Ota has been treated with
the Q-switched alexandrite lasers for
many years. Recently, a large-scale
retrospective study of 806 patients with
three-year follow-up was conducted (Liu
J, Ma YP, Ma XG, et al. Dermatol Surg.
2011;37(10):1480-1485) utilizing fluences
of 3.8 J/cm2 to 4.8 J/cm2, a 3 mm spot
and 50 ns pulse. Overall, 93.9 percent of
patients achieved complete clearance
after an average of 5.2 sessions.
n Vascular lesions — port wine stains:
Port wine stains are often treated with the
pulsed dye laser (PDL), but over time port
wine stains can become unresponsive
to the PDL, and nodules develop. These
recalcitrant vessels can be treated with
the alexandrite laser that targets both
deoxyhemoglobin and oxyhemoglobin
chromophores. Moreover, the 755 nm
wavelength affords an increased depth
of penetration than other wavelengths
used for vascular lesions such, as the
532 nm potassium titanyl phosphate
and 595 nm PDL (1 mm to 2 mm depth).
Reports indicate that the long-pulsed
755 nm laser can be useful for hypertrophic and treatment-resistant port wine
stains in adult and pediatric patients
(Izikson L, Nelson JS, Anderson RR.
Lasers Surg Med. 2009;41(6):427-432).
n Basal cell carcinoma: A recent report
(Ibrahimi OA, Sakamoto FH, Tannous
Z, et al. Lasers Surg Med. 2011;43(2):6871) suggests the use of the long-pulsed
alexandrite laser in helping to reduce
the tumor burden in basal cell nevus
syndrome. The long-pulsed alexandrite
laser targets the oxyhemoglobin in blood
vessels and penetrates deeply. In this
report of a single patient, there was an
83 percent (15 of 18 basal cell carcinomas) clinical clearance, without
histological evidence of residual tumor.
Although this represents a single case,
it does offer an alternative therapeutic
modality for this challenging condition.
lesions. One look at the photo of the ovoid,
distorted pupil of a 33-year-old woman
on the cover of the March 2007 issue of
Archives of Dermatology underscores this
point (Hammes S, Augustin A, Raulin C, et
al. Arch Dermatol. 2007;143(3):392-394).
Protecting the eyes with gauze and aiming
the long-pulsed 755 nm laser away from
the orbit were the safety measures used
instead of intraocular shields while treating
a PWS, and the results were devastating.
A more recent report of the long-pulsed
alexandrite laser causing irreversible pupil
damage in the ophthalmology literature
(Lin CC, Tseng PC, Chen CC, et al. Graefes
Arch Clin Exp Ophthalmol. 2011;249(5):783785) underscores this point.
Although the 755 nm alexandrite is a
relatively young wavelength in dermatologic laser surgery, its effectiveness and
versatility make it a highly attractive option
in a laser surgeon’s armamentarium. DT
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As with all lasers, proper protective
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as port wine stains, hair and pigmented
45
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46
cutaneous oncology
Dermatology Times
49
50
|
January 2012
PDT popularity
Ongoing experience boosts
therapy’s value
Holding out hope
Recent epidemiology data for
melanoma remains grim, but clinical
advances offer reason for optimism
Up close and personal
RCM enables physicians to view suspect lesions with greater magnification, clarity
By Ilya Petrou, M.D.
Senior Staff Correspondent
G r a z , A u s t r i a — Ref lec t a nce
confocal microscopy (RCM) is a
relatively new technique that can help
clinicians more accurately evaluate
both melanocytic and nonmelanocytic skin lesions. It may even
negate the need for biopsy in certain
instances, an Austrian dermatologist says.
“One of the great advantages of
confocal microscopy over traditional light dermoscopy is that you
get a much higher magnification of
the lesions. When using the device,
you are able to clearly view an area
down to the cellular level, giving
you a much more precise picture
of the lesion under scrutiny,” says
Rainer Hofmann-Wellenhof, M.D.,
professor, department of dermatology, Medical University of Graz,
Austria.
RCM works by focusing a laser
beam on a specif ic point in the
tissue. The ref lected light shows
architectural and cellular details
at a spatial resolution of about 1
micron. According to Dr. HofmannWellenhof, these sharp black-andwhite detailed images, similar to
ultrasound images, would be blurred
when viewed with conventional light
dermoscopy.
Dr. Hofmann-Wellenhof says he
uses the VivaScope 1500 (Lucid)
confocal imager.
Virtual biopsy
Conventional light dermoscopy is
performed using a liquid interface
and physical contact with the skin,
allowing more light to penetrate past
the stratum corneum. The confocal
microscope uses spatial filtering
techniques, and incorporates the
ideas of point-by-point illumination
and rejection of out-of-focus light
or glare in lesions that are thicker
than the focal plane, Dr. HofmannWellenhof says.
The removal of this “visual noise”
results in a much sharper image and
allows the clinician to evaluate the
viewed lesion at the cellular level, he
says.
“Confocal microscopy, in essence,
can serve as a virtual biopsy,” he
says. “In some cases, the device may
Severe sun damage
Even after careful clinical examination with the naked eye and with
light dermoscopy, Dr. HofmannWellenhof says some skin lesions
can still be difficult to accurately
diagnose. This is particularly true
for lesions occurring in severely sundamaged skin such as in the face,
neck and décolletage.
“One of the great
advantages of confocal
microscopy ... is that you
get a much higher
magnification of the
lesions.”
Rainer Hofmann-Wellenhof, M.D.
Medical University of Graz, Austria
Many of the melanocy tic and
nonmelanocytic lesions occurring in
DT Extra New staining test assesses moles
“Nearly everything has changed
about how we are using PDT.”
Roger I. Ceilley, M.D.
Des Moines, Iowa
On improvements to photodynamic therapy
See story, page 49
A new diagnostic staining test created by investigators at Weill Medical College can help determine
whether a mole is benign or cancerous. The test
uses the soluble adenylyl cyclase (sAC) expression
pattern, with melanoma predicted if sAC is present in
the nucleus of cells from skin biopsies. Most current
diagnostic staining tests highlight a particular cell
in a biopsy, with more “intense” stains predicted as
melanoma — but definitions of “intense” are objective
with these tests.
Source: Medical News Today
Top: Getty Images/Lifesize/
John Rensten; Left: Skin Cancer
Getty Images/Collection/Credit
Foundation
Quotable
Advanced dermoscopy technique
gives clinicians a closer view of
suspicious lesions noninvasively.
help avoid the need for superfluous
surgical biopsies that might have
otherwise been necessary in suspicious lesions with an unclear diagnosis following light dermoscopy.”
January 2012
|
these areas often mimic one another
phenotypically, he says. This can be
true for lentigines, actinic keratosis,
pigmented Bowen disease, lentigo
maligna and flat
Dr. Wellenhof
seborrheic keratosis. Furthermore, all of these
lesions cou ld
be mistaken for
melanoma.
“Bot h melanocytic and
nonmelanocytic
skin lesions
located on the face are sometimes
very difficult to diagnose because
the skin in this area has a different
morphology resultant from chronic
s u n d a m a g e ,” D r. H o f m a n n Wellenhof says.
“Particularly true for facial skin,
confocal microscopy helps you to
much easier differentiate whether the
47
cutaneous oncology
DermatologyTimes.com
“Particularly true for facial skin, confocal microscopy
helps you to much easier differentiate whether the
cells viewed in the lesions are benign or malignant.”
Rainer Hofmann-Wellenhof, M.D.
Medical University of Graz, Austria
Wellenhof says. Using the device, one
can quickly and accurately establish
the nature of the pigmentation seen
RCM see page 48
For the symptoms of
psoriasis and severe eczema
6JGUVTGPIVJ
QHCJKIJRQVGPE[
UVGTQKFKPCOQKUVWTK\KPI
DCUG
t Diflorasone diacetate demonstrated
clinical efficacy in treating the
signs and symptoms of psoriasis
and eczema1-3
t Provides the benefits of an
emollient-based formulation in
a cream vehicle4-6
t Offers flexible QD–TID dosing options
based on severity7
RCM image of a melanocytic nevus.
Regular refractile melanocytes are
forming a regular ring-like pattern. (Photos: Rainer Hofmann-Wellenhof, M.D.)
Instant Savings Card
t Available for eligible patients
Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations
of corticosteroid-responsive dermatoses.
Safety Information
Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the
components of the preparation.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and
glucosuria in some patients.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus
be more susceptible to systemic toxicity (please see adjacent page for full Prescribing Information).
RCM image of a melanoma. Irregular
refractile melanoma cells are distributed in architectural disarray.
cells viewed in the lesions are benign
or malignant,” he adds.
The confocal microscopy technique also can be useful in the assessment of recurrent lesions and hypoor amelanotic lesions, Dr. Hofmann-
References: 1. Squires DJP, Masson EL. An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. J Int Med Res. 1981;9(1):79-81. 2. Lawless JF,
Stubbs SS. Comparative efficacy of once-a-day diflorasone diacetate and T.I.D. hydrocortisone in treating eczematous dermatitis. Curr Ther Res. 1978;23(2):159-165. 3. Lebwohl MG,
Medansky RS, Savin RC, Alton AV. Diflorasone diacetate cream in an optimized vehicle versus fluocinonide cream for the treatment of psoriasis. J Dermatol Treat. 1995;6:219-222.
4. Clark C. How to choose a suitable emollient. Pharm J. 2004;273:351-353. 5. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection.
Skin Therapy Lett. 2005;10(5):1-8. 6. Factsheet: emollients. National Eczema Society Web site. http://www.eczema.org/Factsheet_Emollients.pdf. Accessed May 2, 2011.
7. ApexiCon® E Cream [Prescribing Information, 2008]. Melville, NY: PharmaDerm, a division of Nycomed US Inc.
APEXICON is a registered trademark of PharmaDerm, a division of Nycomed US Inc.
©2011 PharmaDerm, a division of Nycomed US Inc. Melville, NY 11747. All rights reserved. 98NAPE030611
,SLNHU[S`LMMLJ[P]L
48
Dermatology Times
cutaneous oncology
RCM from page 47
in and around the scar and establish
whet her it is a recurrent lesion
(i.e., nevus, melanoma or other) or
simply nondescript benign pigmentation.
Selective use
View ing a sing le lesion w it h
confocal microscopy can take 10 to
15 minutes, compared to only a few
seconds when using traditional light
dermoscopy. Because the procedure
is much more time consuming, Dr.
Hofmann-Wellenhof suggests that
the confocal technique be reserved
on ly for suspicious or selec ted
lesions.
Though a ref lectance confocal
microscope can be a costly venture,
D r. Ho f m a n n-We l l e n h o f s ay s
investment in the device is worth-
|
January 2012
while, as it can significantly help in
determining an accurate diagnosis
of worrisome lesions.
“Confocal ref lectance microscopy is a relatively new and fascinating diagnostic tool that I believe
will become more and more important in the noninvasive assessment
of melanocytic and nonmelanocytic
Because the procedure
is much more time
consuming,
Dr. Hofmann-Wellenhof
suggests that the confocal
technique be reserved
only for suspicious or
ApexiCon E Cream (diflorasone diacetate cream USP 0.05%[emollient])
®
ApexiCon
Cream
®
(diflorasone diacetate cream USP 0.05% [emollient])
Rx only
NOT FOR OPHTHALMIC USE
DESCRIPTION: Each gram of ApexiCon® E Cream (diflorasone diacetate cream USP 0.05%
[emollient]) contains 0.5 mg diflorasone diacetate in a cream base for topical dermatological
use.
Chemically, diflorasone diacetate is: 6p,9-difluoro-11q,17,21-trihydroxy-16q-methylpregna-1,4diene-3,20-dione 17,21-diacetate.
The structural formula is represented below:
O
CH2OCCH3
C=O
H
CH3
HO
CH3
CH3
H
H
F
O
OCCH3
H
O
F H
Each gram of ApexiCon E Cream (diflorasone diacetate cream USP 0.05% [emollient]) contains: 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol,
stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified
water.
CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest
that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the
use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant
dermatoses. (See DOSAGE AND ADMINISTRATION.)
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic
pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted
by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted
into the bile.
INDICATIONS AND USAGE: Topical corticosteroids are indicated for relief of the inflammatory
and pruritic manifestations of corticosteroid responsive dermatoses.
CONTRAINDICATIONS: Topical steroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.
PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome,
hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use
over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or
under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression
by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted,
an attempt should be made to withdraw the drug, to reduce the frequency of application, or to
substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic
corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more
susceptible to systemic toxicity. (See PRECAUTIONS: Pediatric Use).
®
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Information for the Patient: Patients using topical corticosteroids should receive the following
information and instructions:
1. This medication is to be used as directed by the physician. It is for external use
only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder
other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped
as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under
occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or
plastic pants on an infant or child being treated in the diaper area, as these garments may constitute occlusive dressings.
Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free-cortisol test; ACTH stimulation test.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have
not been performed to evaluate the carcinogenic potential or the effect on fertility of topical
corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when
administered systemically at relatively low dosage levels.The more potent corticosteroids have
been shown to be teratogenic after dermal application in laboratory animals. There are no
adequate and well-controlled studies in pregnant women on teratogenic effects from topically
applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be
used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether topical administration of corticosteroids could result
in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically
administered corticosteroids are secreted into breast milk in quantities not likely to have a
deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use: Safety and effectiveness of diflorasone diacetate emollient cream in pediatric
patients have not been established. Because of a higher ratio of skin surface area to body
mass, pediatric patients are at a greater risk than adults of HPA-axis suppression when they
are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on
treatment. Adverse effects including striae have been reported with inappropriate use of topical
corticosteroids in pediatric patients.
HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported
in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in
pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol
levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least
amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may
interfere with the growth and development of pediatric patients.
ADVERSE REACTIONS: The following local adverse reactions have been reported with
topical corticosteroids, but may occur more frequently with the use of occlusive dressings.
These reactions are listed in an approximate decreasing order of occurrence: burning, itching,
irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy,
striae, and miliaria.
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to
produce systemic effects. (See PRECAUTIONS).
DOSAGE AND ADMINISTRATION: ApexiCon® E Cream (diflorasone diacetate cream USP
0.05% [emollient]) should be applied to the affected areas as a thin film from one to three times
daily depending on the severity or resistant nature of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If
an infection develops, the use of occlusive dressings should be discontinued and appropriate
antimicrobial therapy initiated.
HOW SUPPLIED: ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) is
available in the following size tubes:
NDC 0462-0395-30
NDC 0462-0395-60
30 gram tube
60 gram tube
Store at controlled room temperature 20° - 25°C (68° -77°F) [see USP].
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com
I8395C/IF8395C
#35
R1/08
selected lesions.
nevi and other skin lesions,” he says.
“The dev ice does not replace
traditional light dermoscopy, but
instead it shou ld be used as an
adjunctive tool during clinical skin
examination, particularly in suspicious lesions.”
D r. H o f m a n n -We l l e n h o f i s
co-aut hor of a new book t it led
Reflectance Confocal Microscopy for
Skin Diseases, which was expected
to be available starting January
2012. DT
Disclosures: Dr. Hofmann-Wellenhof
reports no relevant financial interests.
For more information:
Ahlgrimm-Siess V, Cao T, Oliviero M,
et al. Arch Dermatol. 2011;147(2):264264
Ahlgrimm-Siess V, Massone C,
Scope A, et al. Br J Dermatol.
2009;161(6):1307-1316
Gerger A, Hofmann-Wellenhof R,
Samonigg H, et al. Br J Dermatol.
2009;160(3):475-481
Hofmann-Wellenhof R, Wurm EM,
Ahlgrimm-Siess V, et al. Semin Cutan
Med Surg. 2009;28(3):172-179
January 2012
|
cutaneous oncology
DermatologyTimes.com
PDT improvements
Ongoing experience is making photodynamic therapy increasingly valuable
By Cheryl Guttman Krader
Senior Staff Correspondent
Getty Images/Digital Vision/Kathy Quirk-Syvertsen
Las Vegas — Accumulating expe-
rience with photodynamic therapy
(PDT) has led to an expanding list of
applications and new protocols that
together have made PDT an increasingly valuable tool in the management
of actinic keratosis (AK) and nonmelanoma skin cancer (NMSC), says Roger
I. Ceilley, M.D., clinical professor of
dermatology, University of Iowa, and
a private practitioner in Des Moines
who spoke at the 30th Fall Clinical
Dermatology Conference.
“Today ... nearly everything has
changed about how we are using PDT,
and most of what we are doing is offlabel,” he says.
Compared with the protocols used
to gain Food and Drug Administration approval, methods for PDT have
become more practical as they are
using shorter photosensitizer incubation times and a variety of light
sources, Dr. Ceilley says.
Although per the product labeling,
PDT using 5-aminolevulinic acid
20 percent (5-ALA; Levulan Kerastick,
DUSA) for AKs should be done with
an incubation time of 14 to 18 hours
and irradiation for 1,000 seconds
using the proprietary blue light source
(BLU-U, DUSA), there are now data
showing good efficacy when treating
nonhyperkeratotic AKs using an
incubation time of just one hour and
irradiating with alternative light
sources, including the pulsed dye laser
and intense pulsed light (IPL) devices.
“The shorter incubation time has
made PDT a lot easier because we
can apply the photosensitizer and
complete the light treatment on the
same day, and the irradiation step
is performed whenever a treatment
Photodynamic therapy with two
different photosensitizers is now
being used off-label as field-directed therapy for AKs; to treat lesions
on the extremities; and for certain
nonmelanoma skin cancers.
room becomes available,” Dr. Ceilley
says.
Field-directed therapy
PDT is now being widely used for
field-directed therapy. In various
approaches, it may be used by itself
— with the photosensitizer applied
directly to visible lesions and then
broadly over the area of photodamage
— or in sequential combinations,
beginning with cryosurgery or topical
medical therapy to target visible
lesions followed by field-directed
therapy with PDT.
Dr. Ceilley says he has found retinoid pretreatment especially helpful
for AKs at more challenging anatomic
locations (the extremities and scalp),
although he adds that it seems to work
best in men and using tazarotene
0.1 percent gel (Tazorac, Allergan).
Patients are directed to apply the
topical retinoid for one to two weeks
prior to PDT.
“Using PDT, we can achieve a good
initial clearance rate and durable
results with a treatment that is reasonably well tolerated and has a good
cosmetic outcome,” Dr. Ceilley says.
NMSC uses
PDT using methyl aminolevulinate
16.8 percent cream (MAL; Metvixia,
Galderma) and a red light source
(Aktilite, Photocure) is also approved
for the treatment of nonhyperkeratotic
AKs on the face and scalp in immuno-
competent patients, and results from
clinical trials demonstrate its efficacy
relative to other standard therapies.
However, compared with 5-ALA,
MAL achieves deeper penetration
at its site of application, and the red
light used for its activation also offers
deeper penetration than the blue light
used for activating 5-ALA. While
there are reports of using both 5-ALA
PDT and MAL PDT effectively for
treating Bowen disease and superficial basal cell carcinoma (BCC), the
“The availability of PDT
is really an important
service for many
patients.”
Roger I. Ceilley, M.D.
University of Iowa
penetration characteristics of MAL
may make it particularly attractive for
these lesions, Dr. Ceilley says.
Dr. Ceilley notes that his clinical
experience and a number of published
articles provide evidence supporting
the use of PDT for prevention of squamous cell carcinoma in chronically
immunosuppressed organ transplant
patients. For this use, cyclic treatment,
repeating PDT every three to six weeks
initially and then several times per
year, seems to work best.
As a consequence of other medications being taken, these patients may
have an increased reaction to the
PDT, but that may be mitigated by
decreasing the incubation time and
light dose, Dr. Ceilley says. DT
Disclosures: Dr. Ceilley reports no relevant financial interests.
49
Dermatology Times
cutaneous oncology
|
January 2012
Cancer advancements
Recent epidemiology data for melanoma serves up good — and bad — news
By Cheryl Guttman Krader
Senior Staff Correspondent
Las Vegas — Although derma-
tologists may be disheartened by
the latest melanoma epidemiology
data showing continued rises in
incidence and the annual number
of melanoma-related deaths, recent
advances in prevention, diagnosis
and treatment should raise hope for
the future, according to Darrell S.
Rigel, M.D., who spoke at the 30th
Annual Fall Clinical Dermatology
Conference.
“There are still areas where we
need to do better, especia lly in
identifying risk factors. However,
research in melanoma is a ver y
dynamic area, and we can expect
to see more new developments on
the horizon,” says Dr. Rigel, clinical
professor of dermatology, New York
University Medical Center.
In 2011, the lifetime risk of invasive melanoma in the United States
was estimated to be one in 57, and
that number is expected to worsen to
one in 50 by the year 2015. When in
situ lesions are included, the current
lifetime risk of getting any kind of
melanoma rises to one in 33, Dr.
Rigel says.
O t her d at a a l s o u nd er s c ore
the importance of melanoma as a
significant public health problem.
It is now the fifth most common
cancer among American men and
the seventh most common cancer
a mong American women. In
addition, melanoma has the thirdhighest mortality rate when ranked
with other major cancers, and it is
also one of only three cancers for
which mortality rates are increasing.
Dr. Rigel notes there is some good
news to be found in recent epidemi-
Diagnostic evolution
Epidemiology data for melanoma
remains grim, but recent studies
may improve the outlook.
ology data, as the five-year survival
rate for melanoma has continued to
improve. The most recent information shows a five-year survival rate
of 93 percent for persons diagnosed
with melanoma in the United States.
Although methods for diagnosing
melanoma have evolved since the
1960s — with the incorporation of
clinical features (first the ABCDs
and t hen t he ABCDEs) and t he
introduction of dermoscopy — more
recent advances have occurred in the
area of digital imaging, including
confocal microscopy and multispectral digital dermoscopy.
The latter technolog y is now
In 2011, the lifetime risk of invasive melanoma in the
U.S. was estimated to be one in 57, and that number
is expected to worsen to one in 50 by the year 2015.
“However, the bad news is that the
number of people dying from melanoma has continued to increase. In
2011, an estimated 8,790 Americans
will die from melanoma, which is
equivalent to more than one person
every hour,” he says.
Dr. Rigel says the forthcoming
changes to sunscreen labeling based
on the “final” monograph of the Food
and Drug Administration are important, because they will make it easier
for physicians to counsel patients on
choosing an effective sunscreen by
looking at the SPF rating and for the
words “broad spectrum.” As of Oct.
30, 2011, it was yet to be determined
whether labeling for SPF would be
capped at 50+. However, there are
finally standard in vitro test criteria
that a manufacturer must meet in
order to label a product as “broad
spectrum,” indicating the product
provides good protection against
UVA as well as UVB.
available in a commercially available platform (MelaFind, MELA
S c i e n c e s), a n d r e s u l t s f r o m a
recently published, prospective
clinical trial assessing the accuracy
of its performance in diagnosing
more than 1,600 pigmented lesions
s howe d it h a d a s en sit i v it y of
98 percent, correctly identifying
125 of 127 melanomas (Monheit G,
Cognetta AB, Ferris L, et al. Arch
Dermatol. 2011;147(2):188-194).
I n a s u b s t u d y i nc lu d i n g 5 0
randomly selected lesions, the biopsy
sensitivity for 39 dermatologists
with expertise in pigmented skin
lesion ma nagement wa s on ly
78 percent. Comparing the results of
the imaging technique with the individual dermatologists showed that
the multispectral digital dermoscopy performed as well as the four
best dermatologists.
“I tend to be very skeptical about
new diagnostic technology for mela-
Getty Images/Image Source
50
January 2012
|
DermatologyTimes.com
noma, but these results are very interesting,” Dr. Rigel says.
A study by Dr. Rigel investigating the impact of information from the multispectral digital imaging device on biopsy
decision-making showed that diagnosis of melanoma could
be improved by incorporating data from this highly sensitive
diagnostic instrument. When dermatologists had access to
the instrument’s diagnosis in addition to the patient’s history,
clinical findings and dermoscopy images, the sensitivity for
their melanoma biopsy decisions improved dramatically. This
benefit occurred with a small drop in specificity, as the imaging
information prompted a few more biopsies that proved to be
unnecessary, Dr. Rigel says.
“However, that is an acceptable trade-off because guided by
the imaging information, the number of melanomas missed
was much less,” Dr. Rigel says.
Other devices for diagnosing melanoma based on different
principles are also under development. A platform that
measures electrical bioimpedance in order to detect differences
in electrical resistance between malignant and nonmalignant
cells is in phase 3 testing in Europe and is expected to begin
investigation in the United States.
For dermatologists who are concerned that these new
machines will eliminate the need for dermatologists’ diagnostic
expertise, results of a prospective study comparing the performance of dermatologists using their clinical acumen with
standard dermoscopy equipment against primary care physicians (PCPs) using an automated diagnostic system (SolarScan,
Polartechnics) provides some reassuring news (Dreiseitl S,
Binder M, Hable K, et al. Melanoma Res. 2009;19(3):180-184),
Dr. Rigel says.
“The sensitivity rate was significantly higher for the dermatologists, and the reason is because the PCPs didn’t know which
lesions to image. This study shows that nothing replaces a good
set of well-trained eyes,” he says.
Treatment advances
Although attempts at developing melanoma vaccines have
yielded disappointing results, there has been important
progress in the area of targeted therapies. So far, multiple
molecular targets have been identified, but the most studied
is the BRAF activated MAP-kinase pathway, and the first oral
BRAF-inhibitor for treatment of BRAF V600E mutation-positive
metastatic melanoma (vemurafenib, previously PLX4032;
Zelboraf, Plexxikon/Roche) was recently approved.
Development of BRAF inhibitors was based on the finding
that about 60 percent of melanomas have a mutation in BRAF
that keeps the MAP-kinase pathway constantly signaling and
promoting melanoma cell growth. By blocking the signaling,
BRAF inhibitors are able to block melanoma cell proliferation,
Dr. Rigel says.
However, while BRAF inhibitor therapy has been associated
with high initial tumor response rates, the duration of benefit
can be short-lived because the tumor acquires resistance.
Researchers have also been identifying strategies to overcome
the resistance, and based on available data, some combination
therapies appear promising, Dr. Rigel says. DT
Disclosures: Dr. Rigel is a consultant for MELA Sciences.
52
practice management
Dermatology Times
business consult
54
Elizabeth Woodcock
is the principal of
Woodcock & Associates
and a speaker and writer
specializing in practice
management. Visit
her website at www.
elizabethwoodcock.com.
|
January 2012
Easing the load
Nonphysician providers
can take over variety of tasks
Navigating no-shows
Much can be done to manage the impact of missed appointments
Quotable
appointment, stop giving them “prime
time” appointments, such as the first slot
of the day. After two missed appointments,
start offering these patients visits on a
standby basis only (e.g., double-book the
appointment, as noted above, advising
them that they will likely have to wait).
Consider a policy of dismissing patients
after the third no-show, but be aware
of potential hazards when dismissing
patients. Discuss your policy, as well as
your protocols for the dismissal process
itself, with your malpractice carrier before
implementation.
Double-book patients
who have failed to show
up multiple times in the
past.
Review schedules. Review the day’s
schedule to spot obvious no-shows, such
as a patient who was just seen yesterday
for an acute appointment. While you are
searching for open slots, identify opportunities for accommodating patients with an
acute need, such as a follow-up appointment that you know is going to be a quick
one. Every morning, it pays to review the
day’s agenda with your clinical support
staff and scheduler. Add any advice about
DT Extra
“A longer training time is
usually more advantageous for
both the physician and the PA.”
Jason L. Smith, M.D.
Rome, Ga.
On hiring and training nonphysician providers
See story, page 54
patients who may require some extra
time — a mobility issue, perhaps — or who
have special needs such as an interpreter.
These so-called “huddles” can help the
day run smoothly, and ensure that you
optimize your schedule.
Don’t schedule beyond 180 days.
Think about it: For patients who need an
annual appointment, you hand them a
little card that has an appointment date
and time a year from now. In today’s
fast-paced environment, imagine the
likelihood that the patient still has the card
a year from now, and that the patient will
keep the appointment. That card will likely
be lost in a few days, let alone a year. And
don’t think that a reminder the night before
is going to do the trick if the last time you
informed them was 364 days ago. After
forgetting about the chosen appointment,
your patient is happily on vacation or has
scheduled another commitment.
In today’s troubled economic times
with more patients failing to show for
appointments today than ever before, you
cannot trust your revenue stream to tiny
appointment reminder cards. When you
need to see a patient for a routine followup in, say, 12 months, put a reminder
into your management system to call the
patient 60 days in advance to schedule
the follow-up appointment. Placing these
calls is more time-intensive for your staff,
but considering how much revenue is
Feeling the squeeze?
Is your practice running out of room? Instead of renting or building more space, try starting an hour earlier
(or staying later). Early morning or evening hours are
terrific options if you practice in a group. You and your
colleagues can operate in staggered shifts or share
the responsibilities. Or, consider working through
lunch. You can pick up an extra hour, or — more comfortably — you can take a 30-minute lunch and extend
the day by an additional 30 minutes at either end.
Source: Elizabeth Woodcock, M.B.A., C.P.C., F.A.C.M.P.E.
Getty Images/Photodisc/Ryan McVay
G
aps in the daily schedule
waste your time and money.
More often than not, these
unintended gaps are the
result of patients who cancel at the last
minute or just don’t show up.
Because you bear all of the overhead
costs for the staff, facility and other costs
related to each appointment time slot, a
“no-show” is a direct hit on your dermatology practice’s bottom line; therefore, it
pays to prevent them from happening. Try
these ideas to solve the no-show problems in your practice.
Strategically overbook. Airlines do
this to keep their planes full. You can, too,
but be strategic. Examine your no-shows.
Look for patterns based on payer, visit
type, time of day, office location, etc.
Start overbooking slightly based on the
patterns you identify — for example, a
particular payer whose beneficiaries have
more frequent no-shows. If you can’t
identify any patterns but you’re plagued
with a no-show problem, consider doublebooking one or two appointments slots
in the morning and another couple in the
afternoon. At minimum, double-book
patients who have failed to show up
multiple times in the past.
Target no-shows. When patients
miss appointments, enter a code for
“failure to show for appointment” in their
scheduling record. After the first missed
January 2012
|
practice management
DermatologyTimes.com
lost when a patient doesn’t show up, this
strategy is a less costly alternative.
If you want to continue to schedule
these far-in-advance appointments, beef
up your confirmation process considerably. In fact, it’s a growing trend to confirm
all previously scheduled appointments 30
days in advance, as well as the traditional
36 hours prior.
Rethink reminders. A telephone call
the night before the appointment works
great for patients to jog their memory, but it
also may be the reminder they need to tell
you they can’t make it. If you call the night
before, you leave no opportunity to rebook
the slot when the scheduled patient
cancels. Call 36 hours prior to the appointment; it allows the patient a full day to call
you should they want to cancel.
Personal reminder calls are great, but
it can get expensive in terms of staff time.
In a busy front office, these calls often get
shoved to the bottom of the daily to-do
list, and they may not be performed at all.
Consider using an automated reminder
system “voiced” by you or one of your
staff. Continue making personal calls
to new patients, patients scheduled for
procedures and patients you’ve identified as more likely to miss appointments.
These problematic patients may include
self-pay patients, Medicaid patients, or
patients who were “bumped” from another
appointment because of a provider’s lastminute emergency.
Make it easy to cancel. Of course
you don’t want patients to cancel, but
why make them jump through hoops
— wait on hold, call only during office
hours, etc.? Importantly, if you don’t know
about their intention to cancel, you won’t
be able to “refill” that slot. Facilitating a
timely cancellation means that you can
get another patient into that appointment
slot. Set up a phone option to give callers
“CMS policy allows physicians ...
to charge Medicare beneficiaries
for missed appointments, provided
that they do not discriminate against
Medicare beneficiaries but also
charge non-Medicare patients
for missed appointments and the
charges for Medicare and nonMedicare patient are the same. The
charge for a missed appointment
is not a charge for a service itself ...
but rather is a charge for a missed
business opportunity.”
Source: MLN Matters 5613, Centers for Medicare & Medicaid Services, www.cms.hhs.gov/
MLNMattersArticles/downloads/MM5613.pdf
a direct connection to scheduling; establish a voicemail box or email account for
after-hours messages and check it every
morning. Use an online patient portal
to accept cancellations. Publicize your
speedy cancellation process in patient
literature, appointment reminders and on
your practice’s website.
It’s a growing trend to
confirm all previously
scheduled appointments
30 days in advance, as
well as the traditional 36
hours prior.
Refill the slot. Maintain a wait list of
patients from which to pull names for open
slots. For patients who want to be seen
earlier but there are no available slots from
which to choose, offer them a spot on your
“priority” list. Maintain a spreadsheet on
your intranet with fields for the patient’s
name, originally scheduled appointment
and cell phone. When a cancellation is
received, look to the list to refill the slot.
If you’re on the campus of a health
system or other large office building,
consider maintaining a separate wait list
for patients who are close by. A patient who
works on the floor above yours, for example,
may be quite pleased to fill the slot of a
patient who cancelled 30 minutes ago.
Charge ’em. In the fall of 2007,
Medicare opened the door to charging
patients for missed appointments. (See
the colored box to the left for details of
the Centers for Medicare & Medicaid
Services policy.) Most patients, however,
don’t respond with payment. Charging
for no-shows can get expensive when
supplies, postage and other billing costs
are added. More importantly, it’s arguable
whether the policy changes behavior,
which is the goal.
Take a stepwise approach to get the
maximum effect from a no-show fee.
Threaten the charge on the first offense,
and then follow through on the second
incident. It will make the burden of the
billing and collection process more
manageable, and it will get the outcome
you’re looking for: behavior change.
Some practices fight the no-show
problem by taking the patient’s credit card
number as a “down payment,” particularly when a procedure is scheduled.
Using this tactic for new patients might
53
be problematic because they would not
have the opportunity to read and sign
an agreement for you to assess this fee.
State and federal laws concerning credit
card transactions without the customer’s
written agreement may come into play.
Established patients can be asked to read
and sign a credit card deduction policy,
but consider whether you have the internal
processes in place to securely manage
and process hundreds of credit card
numbers. If not, search for a secure, and
ideally automated, solution.
Schedule pre-appointments. When
a procedure is scheduled, the impact of a
no-show can be even greater, considering
the additional time that has been set aside
on the schedule. The risk is especially
high when it is a new patient who has been
referred to you. One way to jump-start the
relationship with a patient is for your office
to perform a pre-appointment “screening”
that can include reviewing history,
completing registration paperwork and
providing a deposit. It requires an investment of time on the patient’s part, but it
helps engage the patient in the relationship with you, and it makes it less likely that
they’ll miss the scheduled appointment.
Dermatology practices nationwide
report an increase in missed appointments.
With the
economy
seemingly
stuck in
recovery
mode,
Americans
continue
to spend
cautiously,
and their
efforts to
save money
can include
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foregoing
elective
procedures
and preventive care. If
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from rising
񡑤񡑨∋񡑀񡑗#񡑱!(񡑃񡑀񡑖񡑔
no-shows,
don’t brush
it off as
a pesky,
operational
issue. Take
񡑥(񡑀)񡑱∗񡑱)−񡑱񡑀/(,)񡑀+#񡑩∃񡑱+∗񡑃񡑀
action. DT
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Dermatology Times
practice management
|
January 2012
Helping hands
Nonphysician providers highly useful in busy dermatology practices
By Ilya Petrou, M.D.
Senior Staff Correspondent
R o m e , G a . — A nonphysician
provider can be an invaluable resource
in a busy dermatologic practice. Given
the proper training and the appropriate
time to gain the experience needed,
nonphysician providers can help to
significantly shorten the wait time of
patients, which can lead to an increased
volume of clientele while decreasing
the workload of the dermatologist, says
one physician.
Physician assistants (PAs) and nurse
practitioners can ease the workload in
a busy practice, as they can take over
many of the tasks typically performed
by the physician. Appropriately
training these nonphysician providers
is crucial to their effective integration
into a busy dermatology office.
“One of the biggest challenges in
regards to the integration of a physician extender is their training. It can
be very time intensive for the supervising physician
Dr. Smith
to train the physic i a n a s si s t a nt
or nurse practitioner. However,
a good and solid
training from the
beginning will
often result in a
more smoothly
r u nning practice later,” says Jason L. Smith, M.D.,
Northwest Georgia Dermatology,
Rome, Ga.
Training tips
Nonphysician providers may need
to shadow the physician during the
busy office day for three to six months
so they can learn how the physician
handles patients and cases.
take histories and complete physical
exams,” he adds.
One of the keys to a smooth
integration of nonphysician
providers is to allow them to
learn at their own pace.
According to Dr. Smith, the longer
a PA follows a physician during the
training period, the more effective he
or she will be after completing training.
“A longer training time is usually
more advantageous for both the physician and the PA in the long term,” he
says. “Not only will a better-trained PA
feel more comfortable seeing derma-
Consistency of care
According to Dr. Smith, a consistency
of patient care between the physician
and the PA is crucial. Patients should
be made aware at the beginning of
a consultation if they are seeing the
physician assistant and not necessarily
the physician.
The physician should always be on
site in case the PA needs assistance
in challenging cases or if the patient
requests that the physician answer any
Physician assistants and nurse practitioners can
ease the workload in a busy practice, as they can
take over many of the tasks typically performed by
the physician.
tologic problems on their own, but the
physician can be more at ease knowing
that their PA is well trained.
“They know the PA’s level of knowledge and expertise as well as their
comfort level in solving dermatologic
problems and issues,” Dr. Smith says.
Delegating responsibilities to the
new PA is an important aspect of the
integration process, and Dr. Smith says
it’s equally important that the office
staff know what tasks the PA is allowed
to perform.
“Physician extenders may see
everything from warts to bullous
pemphigoid to skin cancer. They see
whatever is put on the schedule, as we
do,” he says.
“Though they do not do as many
procedures as the physician, they will
see the full gamut of dermatology,
perform many the biopsies as well as
outstanding questions they may have.
The quicker PAs are integrated into
the office routine, the sooner they
will be able to see and handle patients
on their own. Once they can operate
without the presence of the physician
and their level of comfort is established,
staff members can schedule patients for
them and better calculate how much
time the PA will require for a given
patient or dermatologic case.
“Once the PA reaches a certain level
of comfort in the routine and rhythm
of a dermatologic practice and typical
cases seen, appropriate scheduling can
be made with their patients, including
how many patients per hour and how
many new patients they can see,” Dr.
Smith says.
“They are not only learning dermatology, but also learning how to operate
Helping see page 57
Getty Images/the Agency Collection/SelectStock
54
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The following adverse experiences have been reported with the topical use of
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following video presentations highlighting the steps involved when applying medication from a pump and a tube.
References: 1. Bissett D. Topical niacinamide and barrier enhancement. Cutis. 2002;70(suppl 6):8-12.
2. Data on file. Galderma Laboratories, L.P. 3. Dow G, Basu S. A novel aqueous metronidazole 1% gel
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METROGEL® (metronidazole) Gel, 1%
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CONTRAINDICATIONS
METROGEL is contraindicated in those patients with a history of hypersensitivity to
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WARNINGS AND PRECAUTIONS
• Peripheral neuropathy, characterized by numbness or paresthesia of an extremity
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• Metronidazole is a nitroimidazole and should be used with care in patients with
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ADVERSE REACTIONS
Most common adverse reactions (incidence >2%) are nasopharyngitis, upper
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In a controlled clinical trial, 557 patients used metronidazole gel, 1% and
189 patients used the gel vehicle once daily for up to 10 weeks. The following table
summarizes selected adverse reactions that occurred at a rate of ≥1%:
Table 1: Adverse Reactions That Occurred at a Rate of ≥1%
System Organ Class/Preferred Term
Metronidazole
Gel
Gel, 1%
Vehicle
N=557
N=189
Patients with at least one AE
Number (%) of Patients
186 (33.4)
51 (27.0)
Infections and infestations
76 (13.6)
28 (14.8)
Bronchitis
6 (1.1)
3 (1.6)
Influenza
8 (1.4)
1 (0.5)
Nasopharyngitis
17 (3.1)
8 (4.2)
Sinusitis
8 (1.4)
3 (1.6)
Upper respiratory tract infection
14 (2.5)
4 (2.1)
Urinary tract infection
6 (1.1)
1 (0.5)
Vaginal mycosis
1 (0.2)
2 (1.1)
Musculoskeletal and
connective tissue disorders
19 (3.4)
5 (2.6)
Back pain
3 (0.5)
2 (1.1)
Neoplasms
4 (0.7)
2 (1.1)
Basal cell carcinoma
1 (0.2)
2 (1.1)
Nervous system disorders
18 (3.2)
3 (1.6)
Headache
12 (2.2)
1 (0.5)
Respiratory, thoracic and
mediastinal disorders
22 (3.9)
5 (2.6)
Nasal congestion
6 (1.1)
3 (1.6)
Skin and subcutaneous
tissue disorders
36 (6.5)
12 (6.3)
Contact dermatitis
7 (1.3)
1 (0.5)
Dry Skin
6 (1.1)
3 (1.6)
Vascular disorders
8 (1.4)
1 (0.5)
Hypertension
6 (1.1)
1 (0.5)
Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than
Baseline
Metronidazole Gel, 1%
Gel Vehicle
Sign/Symptom
N=544
N=184
Dryness
138 (25.4)
63 (34.2)
Mild
93 (17.1)
41 (22.3)
Moderate
42 (7.7)
20 (10.9)
Severe
3 (0.6)
2 (1.1)
Scaling
134 (24.6)
60 (32.6)
Mild
88 (16.2)
32 (17.4)
Moderate
43 (7.9)
27 (14.7)
Severe
3 (0.6)
1 (0.5)
Pruritus
86 (15.8)
35 (19.0)
Mild
53 (9.7)
21 (11.4)
Moderate
27 (5.0)
13 (7.1)
Severe
6 (1.1)
1 (0.5)
Stinging/burning
56 (10.3)
28 (15.2)
Mild
39 (7.2)
18 (9.8)
Moderate
7 (1.3)
9 (4.9)
Severe
10 (1.8)
1 (0.5)
The following additional adverse experiences have been reported with the topical
use of metronidazole: skin irritation, transient redness, metallic taste, tingling or
numbness of extremities, and nausea.
Post Marketing Experience
The following adverse reaction has been identified during post approval use
of topical metronidazole: peripheral neuropathy. Because this reaction is reported
voluntarily from a population of uncertain size, it is not always possible to reliably
estimate the frequency or establish a causal relationship to drug exposure.
DRUG INTERACTIONS
Oral metronidazole has been reported to potentiate the anticoagulant effect
of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug
interactions should be kept in mind when METROGEL is prescribed for patients
who are receiving anticoagulant treatment, although they are less likely to occur with
topical metronidazole administration because of low absorption.
USE IN SPECIFIC POPULATIONS
Pregnancy: Teratogenic Effects: Pregnancy Category B.
There are no adequate and well-controlled studies with the use of METROGEL
in pregnant women. Metronidazole crosses the placental barrier and enters the
fetal circulation rapidly. No fetotoxicity was observed after oral administration
of metronidazole in rats or mice at 200 and 20 times, respectively, the expected
clinical dose. However, oral metronidazole has shown carcinogenic activity in
rodents. Because animal reproduction studies are not always predictive of human
response, METROGEL should be used during pregnancy only if clearly needed.
Nursing Mothers
After oral administration, metronidazole is secreted in breast milk in concentrations
similar to those found in the plasma. Even though blood levels taken after topical
metronidazole application are significantly lower than those achieved after
oral metronidazole a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the mother
and the risk to the infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1%
in the clinical study. No overall differences in safety or effectiveness were observed
between these subjects and younger subjects, and other reported clinical experience
has not identified differences in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled out.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Metronidazole has shown evidence of carcinogenic activity in a number of studies
involving chronic, oral administration in mice and rats, but not in studies involving
hamsters.
In several long-term studies in mice, oral doses of approximately 225 mg/m2/day
or greater (approximately 37 times the human topical dose on a mg/m2 basis) were
associated with an increase in pulmonary tumors and lymphomas. Several long-term
oral studies in the rat have shown statistically significant increases in mammary and
hepatic tumors at doses >885 mg/m2/day (144 times the human dose).
Metronidazole has shown evidence of mutagenic activity in several in vitro
bacterial assay systems. In addition, a dose-related increase in the frequency of
micronuclei was observed in mice after intraperitoneal injections. An increase in
chromosomal aberrations in peripheral blood lymphocytes was reported in patients
with Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for
1 to 24 months. However, in another study, no increase in chromosomal aberrations
in circulating lymphocytes was observed in patients with Crohn’s disease treated
with the drug for 8 months.
In one published study, using albino hairless mice, intraperitoneal administration of
metronidazole at a dose of 45 mg/m2/day (approximately 7 times the human topical
dose on a mg/m2 basis) was associated with an increase in ultraviolet radiationinduced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity
studies have been performed with METROGEL or any marketed metronidazole
formulations.
PATIENT COUNSELING INFORMATION
Patients using METROGEL should receive the following information and instructions:
1. This medication is to be used as directed.
2. It is for external use only.
3. Avoid contact with the eyes.
4. Cleanse affected area(s) before applying METROGEL.
5. This medication should not be used for any condition other than that for which it
is prescribed.
6. Keep out of reach of children.
7. Patients should report any adverse reaction to their physicians.
US Patent No. 6,881,726 and 7,348,317
Marketed by:
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA
P50742-3-BS Revised: November 2011
Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada.
|
practice management
DermatologyTimes.com
Helping from page 54
efficiently and effectively within that
office system,” he explains.
For love of the field
Many nonphysician providers who
join a dermatology practice do so with
purpose and enter the field for very
much the same reasons physicians
choose to practice dermatology, Dr.
Smith says.
“It is not uncommon that physician
extenders in other specialties actively
seek a position in a dermatology practice because they have heard so many
good things about the specialty from
their fellow colleagues, such as the
interesting cases seen, the easier hours
compared to other specialties and the
predictability of dermatology,” Dr.
Smith says.
The quicker PAs are
integrated into the office
routine, the sooner they
will be able to see and
handle patients on their
own.
Dr. Smith currently employs two
nonphysician providers in his office.
Both originally worked in other
specialties — including internal medicine and pediatrics — and now have
found their niche in dermatology.
Nonphysician providers with such
backgrounds can be a great addition to
a dermatology
g office, he says,
y because
they have a wealth of information from
other linked specialties.
“ They w i l l of ten be quick to
recognize many of the diseases and
symptoms seen in those specialties
that overlap with the diseases and
symptoms also seen in dermatology,
including rashes and the typical
dermatologic issues occurring in
diabetic patients,” Dr. Smith says.
Nonphysician providers entering
dermatology with experience and
training in other fields can be very
useful because of the high turnover
of pediatric and internal medicine
patients in the dermatology practice,
he says.
“In my experience, physician
extenders who have already worked in
other specialties such as primary care,
internal medicine or pediatrics find it
easier to learn the ins and outs of the
office and slip in to the dermatology
practice. This is because they have a
great deal of experience with primary
care patients, and that goes a long way,”
Dr. Smith says.
Nonphysician providers who are
fresh out of school can also be advantageous, however, because the dermatologist can teach them the ropes from
scratch and have them learn patient
care catering to the specifics of that
dermatologist and his or her practice,
according to Dr. Smith.
“I have had physician extenders in
my practice with other specialty experience and those fresh out of school,
and in my opinion, both options have
their advantages. The choice of staff
depends on the dermatologist and what
his or her immediate goals are for their
office,” he says.
y
Additional requirements
Dermatologists who take on nonphysician providers may need to hire more
office staff. As a rule of thumb, Dr.
Smith says that for each new nonphysician provider, the hiring of one
— if not two — medical assistants may
be required. These assistants should
be assigned to the new PA to accommodate them as needed.
“I believe that it is critical
that the PA learns at their
own pace and not at the
physician’s expected
pace.”
Jason L. Smith, M.D.
Rome, Ga.
“I believe that it is critical that the PA
learns at their own pace and not at the
physician’s expected pace. A dermatology practice can be very busy, and
the temptation is to start letting PAs
see patients right away and throw them
into cold water in order to take the
burden off the physician. However, this
will not likely improve office efficiency
in the short term,” Dr. Smith says.
Over time, the PA’s comfort level
may reach one similar to that of the
physician, and soon, the practice will
run more efficiently. According to
Dr. Smith, a high level of comfort may
allow PAs to handle 20 to 30 or more
patients a day.
Because the integration of a PA will
lighten the workload in the practice,
the physician may then have the opportunity to concentrate on areas of medicine that he or she may prefer, such as
surgery or cosmetic procedures.
“Dermatology practices are busier
than ever, and patients may often have
to wait weeks or even months to see
their dermatologist,” Dr. Smith says.
“Bringing in a PA can shorten this
waiting time and increase the access of
patients to medical care, which will not
only result in a lighter workload for the
physician but will also improve patient
care,” he explains. DT
Disclosures: Dr. Smith reports no
relevant financial interests.
Getty Images/rubberball
January 2012
57
58
Dermatology Times
|
January 2012
new products
ApoTheDerm
Anti-aging line filled with peptides
A new line of anti-aging products, developed
for normal to dry skin, has four products that
can work alone or synergistically to help fight aging.
Three products have been
formulated with SmartPeptide technology to help
reduce appearance of fine
lines and wrinkles. The firming serum is packed with
two SmartPeptides to provide a boost in anti-aging.
Apothederm moisturizing cream is an emollient
formulation with palmitoyl
hexapeptide-14 that targets fine lines. Apothederm
moisturizing cleanser contains avocado oil, which
nourishes and protects the skin while it cleanses
without stripping skin. Formulated with hexapeptide21, Apothederm hydrating eye cream controls visible
photoaging in the eye area while hydrating the delicate area around the eye, according to the company.
SmartPeptides are a new generation of bioactive
peptides that mimic precise amino acid sequences of
the skin’s own natural protect and restore functions.
The peptides can target a specific skin problem, such
as appearance of fine lines and wrinkles, loss of elasticity, loss of firmness and definition, appearance of
darkened areas or general unevenness of skin tone,
rough texture and thinning of the skin.
For more information:
www.apothederm.com
ellmAn InTernATIonAl
Laser pinpoints fractional resurfacing
The Ellumine CO 2 laser system is a fully
flexible CO 2 laser
system for fractional
resurfacing and
other surgical applications. Ellumine
offers flexibility for a range of treatments from
full fractional skin resurfacing to light touchups, providing optimal patient results with
more gentle treatment and minimal downtime.
Other Ellumine highlights include a compact,
durable and easily portable console with minimal
To have information about your company’s
product or service considered for this
section, send news releases and photos to:
New Products and Services
Dermatology Times
24950 Country Club Blvd.
Suite 200
North Olmsted, OH 44070
or fax to (800) 788-7188
Publication is subject to space availability and
appropriateness, at the editors’ discretion.
setup for office-to-office usage; capacity to provide a
full fractional ablative treatment when needed; flexible
CO2 fiber that allows the clinician easy access to all
areas; and the ability to change treatment settings in
the physician’s hand, the company states.
For more information:
www.ellman.com
www.pelleve.com
www.ellumine.com
SIlIcone ArTS lAbS
Dermal filler touches up scars
Dermaflage, a topical dermal filler, is a noninvasive product designed to bridge the gap between
makeup and plastic surgery, according to the
manufacturer. It features medical-grade products
and ingredients that are approved by the Food
and Drug Administration.
The product works by pressing a small amount of
silicone from the applicator into the recessed area or
blemish. The silicone blend forms a “second skin” to conceal the imperfection, the company says.
Dermaflage is waterproof and resistant to smudges
and smears, and lasts for up to 36 hours. The silicone
moves with the facial muscles, avoiding cracking and
peeling. The product comes in a starter kit that includes
three colors, designed to match most skin tones.
For more information:
www.dermaflage.com
rX SySTemS pF
Reparative serum enriched with extracts
A new reparative eye serum is enriched with
Rx Systems PF’s Glypoic Complex, green and
white tea extracts, avocado oil
and hydrolyzed elastin and collagen to effectively treat aging
and sun damage around the
eye for a more refreshed, youthful appearance without surgery.
Rx Systems PF’s reparative eye
serum was scientifically formulated
to decrease puffiness, dark circles
and crow’s feet around the eyes,
and to firm and tighten the skin in the
eye area, the company states. Formulated for all skin types, the reparative eye serum
is pH-balanced and enriched with Rx Systems PF’s
Glypoic Complex, a blend of 5 percent glycolic acid
and alpha-lipoic acid. The serum also contains antioxidants extracted from the comfrey leaf and green
and white tea, plus avocado oil.
For more information:
www.rxsystemspf.com
leXlI SkIncAre
Exfoliants boost skin long-term
The AloeGlyC aloe-based renewing chemical
exfoliant maintains healthy skin over the long
term. It features certified organic, pharmaceutical-grade aloe vera base, along with its
effective pH of 2.1 to 2.3, due to aloe vera’s
anti-inflammatory properties. Use of this product helps maintain
skin after professional treatments.
AloeGlyC can be
used to extend the
benefit of a professional chemical
peel, according to
the company.
In advance of a chemical peel with a pH of 3 or
higher, clients should use the Lexli four-step skincare
regimen, including AloeGlyC. Use of AloeGlyC should
be discontinued the morning of treatment. When the
skin is no longer red, inflamed, dry and/or flaking, the
patient may again use AloeGlyC Renewing Exfoliant.
For more information:
www.lexli.com
GebAuer
New packaging for skin refrigerant
To enhance delivery of its ethyl chloride topical
anesthetic skin refrigerant, Gebauer Company
launched Accu-Stream 360
with Sure Lock Technology, which uses 45 mm slim
containers, aerosol valves and
actuators.
Gebauer’s ethyl chloride AccuStream 360 products feature
actuator technology, which allows
clinicians to spray the product from
any angle. Sure Lock Technology
on the actuator prevents accidental
dispensing during storage, shipping or periods of
non-use at the office. Slim design of the 45 mm aerosol
container eases dispensing because it is easy to grip
and maneuver, the company states. The product is
available in medium stream and fine stream sprays.
For more information:
800-321-9348
www.gebauer.com
Syneron
Technology aids facial rejuvenation
The latest minimally invasive device, ePrime, is
a radiofrequency-based device that employs
microneedling directly into the dermis to deliver a natural facelift-like result, without surgery.
According to the company, ePrime is clinically
proven to add volume and reduce the appearance of wrinkles and fine lines by boosting the
skin’s natural production of collagen, elastin
and hyaluronic acid. Patients require only one
treatment and will begin to see effects immediately post-treatment with continued improvements of up to three months.
Thanks to ePrime’s Intelligent Feedback Systems,
which measures temperature in real time, physicians
can adjust power levels to meet the needs of different
January 2012
|
59
DermatologyTimes.com
new products
skin conditions and skin types. The procedure takes
less than 1 hour to perform under local anesthesia.
The fractional treatment method also protects the
tissue surrounding the treatment areas, promoting a
quicker healing process, according to the company.
For more information:
www.syneron.com
leD TechnoloGIeS
Light therapy tackles wrinkles
The dpl Nüve light therapy system, which
recently received clearance by the Food and
Drug Administration for its use in treating
wrinkles and acne, along with its previous
clearance for
pain treatment,
is reportedly the
first light therapy
device to treat
three distinct indications.
Deep penetrating light (DPL) therapy helps provide
a younger, smoother complexion without invasive or
expensive clinical procedures. DPL is an all-natural,
noninvasive treatment with no downtime, the company states, and it is easy to use at home.
For more information:
www.ledtechnologies.com
cArDInAl heAlTh
Sterilization wrap fits plasma system
The new DuraBlue sterilization wrap, a doublelayer spunbond/meltblown/spunbond (SMS)
wrap, has clearance from the Food and Drug Administration for use
in the STERRAD
100S plasma sterilization system.
The new Cardinal
Health DuraBlue
sterilization wrap can
help bring efficiencies to the sterilization process while maintaining a
high standard of aseptic technique, according to the
company. Its double-layer construction gives users
time-savings by using the simultaneous wrapping
technique, eliminating the need for double wrapping
with a single-layer wrap.
DuraBlue sterilization wrap is made with non-woven,
polypropylene SMS technology for strength, durability
and microbial protection. The wrap is available in six
color-coded basis weight models, providing protection
for everything from lightweight linen packs to heavy
instrument trays weighing up to 25 pounds.
For more information:
www.cardinalhealth.com
onSeT DermAToloGIcS
Cream available in jar with dispenser
Hylatopic Plus Cream comes in a 450 gram jar
with pump dispenser. Hylatopic Plus cream is
indicated to manage and relieve burning, itching and pain linked with conditions, such as
atopic dermatitis, allergic contact dermatitis
and radiation dermatitis.
The large 450 gram jar is ideal for patients affected by
eczema symptoms on a large surface area. The pump
dispenser also helps avoid contamination of the product,
even with repeated use. Hylatopic Plus Cream is available by prescription only.
For more information:
www.onsetdermatologics.com
60
Dermatology Times
calendar
|
January 2012
ad index
Advertiser
Product
American Dermoscopy
upcoming
events
Dermatology Times lists meeting
announcements for the following three
months in our print issue.
Page
59
Aqua Pharmaceuticals
Monodox
13
Bayer Dermatology
Corporate
31
Beiersdorf
08-09
Compulink Business Systems
15
For a full listing of events, go to www.dermatologytimes.com
Ninth Annual Orlando
Dermatology Aesthetic &
Clinical Conference
MauiDerm 2012 —
Advances in Cosmetic and
Medical Dermatology
Coria Labs
www.orlandoderm.org
Jan. 13-16, 2012
Rosen Shingle Creek
Orlando, Fla.
www.acmd-derm-hawaii.com
Feb. 4-8, 2012
Grand Wailea Resort
Wailea, Hawaii
Foundation for Research
and Education in
Dermatology — 2012
Winter Clinical
Dermatology Conference
Dermatology Nurses’
Association 30th Annual
Convention
www.ClinicalDermConf.org
Jan. 14-19, 2012
Hyatt Regency Maui
Kaanapali, Hawaii
www.dnanurse.org
Feb. 16-19, 2012
Sheraton Denver Downtown Hotel
Denver
Second International
Congress of Aesthetic
Dermatology — ICAD
Florida Society of
Dermatology and
Dermatologic Surgery
2012 South Beach
Symposium
www.euromedicom.com
Jan. 19-21, 2012
Bangkok Int’l. Convention Center
Bangkok
www.southbeachsymposium.org
Feb. 16-20, 2012
Loews Miami Beach Hotel
Miami Beach, Fla.
Melanoma 2012 — 22nd
Annual Cutaneous
Malignancy Update
2012 Canadian Melanoma
Conference
www.scripps.org/events/melanoma-2012
Jan. 21-22, 2012
Hilton San Diego Bayfront
San Diego
Montana Academy of
Dermatology 39th Annual
Winter Meeting
www.billingsclinic.com
Jan. 26-29, 2012
Yellowstone Conference Center
Big Sky, Mont.
www.buksa.com/melanoma
March 1-4, 2012
Rimrock Resort Hotel
Banff, Alberta
Atralin
23-24
Galderma Laboratories Inc
Cetaphil
33
Galderma Laboratories Inc
Metrogel
55-56
Galderma Laboratories Inc
PreBoard
11
Genentech Inc
Hedgehog
18-19
Glaxo Smithkline Inc.
Luxiq
29
Glaxo Smithkline Inc.
Olux
35-36
Glaxo Smithkline Inc.
Veltin
CV3-CV4
Inga Ellzey Practice Group Inc.
KAO Brands
Curel
27
Medical Technology
45
Obagi Medical Products
17
International Society of
Dermatopathology — 15th
Joint Meeting
Ortho Dermatologics
www.intsocdermpath.org
March 14-15, 2012
Westin Gaslamp Quarter
San Diego
Retin-A Micro
CV2-3
Palomar Medical Technologies
Icon
5
Pharmaceutical Specialties Inc
Vaniply
21
Pharmaderm
Apexicon E Cream
47-48
Pharmaderm
Veregen
39-40
Cloderm
Cover Tip
Halog
51
University of Louisville
Winter Skin Seminar
American Academy of
Dermatology 70th Annual
Meeting
http://uofl.me/winterskin12
Jan. 27-31, 2012
The Canyons
Park City, Utah
www.aad.org
March 16-20, 2012
San Diego Convention Center
San Diego
International Academy of
Cosmetic Dermatology
& Mexican Society of
Cosmetic Dermatology
8th World Congress of
Cosmetic Dermatology
10th Anti-Aging Medicine
World Congress
Promius Pharmaceuticals
www.euromedicom.com
March 29-31, 2012
Grimaldi Forum
Monte Carlo, Monaco
Ranbaxy Pharmaceuticals Inc
www.WCOCD2012.com
Jan. 31-Feb. 4, 2012
Fiesta Americana,
Hotel Grand Coral Beach
Cancún, Mexico
43
Women’s Dermatologic Society
53
This index is provided as an additional service. The publisher
does not assume any liability for errors or omissions.
January 2012
|
DermatologyTimes.com
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e
p
u
ifctg
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su
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2
$3
9
.
x-3
5
PRACTICE FOR SALE OR LEASE
W
o
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o
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2
t
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35 year old well established and well
respected Solo Derm practice for sale.
Dr. Busy working 3½ days per week.
No cosmetics performed. All excisions
and Mohs referred out. Multiple avenues
for growth. Office lease and license
up for renewal End of June 2012. Fax
serious inquires ONLY to: 480-948-6069
KENTUCKY
PRODUCTS
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Retiring
Monetization of your practice
Locking in your value now
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ARIZONA
WE ARE THE LEADING EXPERTS IN PRACTICE START-UP
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ELIZABETHTOWN, KENTUCKY
36 YEAR ESTABLISHED FUNCTIONING
PRACTICE
Critical need for a Dermatologist in growing area
near Ft. Knox. Tremendous potential. Office
is a 2-story converted home on 2/3 acres of
commercial land on main traffic route, across
from Hospital with a Human Resource center
located 10 miles from office containing a large
Federally Employed population. Turn-key
operation with experienced staff. Located 40
miles south of Louisville, Kentucky on I-65. Call
or email to discuss generous terms.
Available at (877) 769-6327 derma@windstream.net
or (423) 821-8230 jmgalex@epbfi.com
Call Karen Gerome to place your Products & Services ad at 800.225.4569 ext. 2670 • kgerome@advanstar.com
65
66
Marketplace
Dermatology Times |
January 2012
PRODUCTS & SERVICES
SYMPOSIUMS
Attention
Dermatologists
Attend
The Medical Entrepreneur Symposium
Everything you were not taught in Med School
Marriott Delray Beach
Florida-March 29-April 1, 2012.
Early Bird Registration Discounts Available.
Earn CME’s- Hear from
Experts- Faculty & Agenda Online Go to:
www.TheMedicalEntrepreneur.com
Call 877-809-7525
Learn:
Billing, Getting Paid, Hospital Privileges,
Medicare, Managed Care
Hiring/Firing, Contracts, Legal & Regulatory,
Technologies, EHR, Marketing,
All Office Operations, Entrepreneurship,
Funding Your Next Venture
RECRUITMENT
CALIFORNIA
ILLINOIS
Dermatology Opportunity
In Busy Suburban Southern
California Practice
DERMATOPATHOLOGIST BC/BE
Safe City • Excellent Schools
Near Beaches/Santa Barbara/Los Angeles
CHICAGO/SW SUBURBS
Growing Practice
With 5 Full time BC Dermatologists
Opportunity For Cosmetic Or Derm Path If Desired
Contact
akaufman@dermatology-center.com
Or Fax CV’s to 805-449-4184
Please Call Lori 708-460-7890
Fax resume 708-460-5537
Email: swderm@yahoo.com
FLORIDA
Marketplace
SARASOTA BAYFRONT
• Growing Dermatology Practice
• Ready for Associate
• Medical/Surgical/Cosmetic
“Practice like you dreamed about”
Fax (941)951-1966
Can Work For You!
★
Southeast Coast
• Lucrative, well-established basic and skin
cancer oriented practice seeks FT
• BC/BE, MD/DO - Associate Needed
“ Beautiful Year round Climate and Beaches”
Call 561-498-2028
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Reach highly-targeted,
market-specific business
professionals, industry
experts and prospects by
placing your ad here!
CONNECT
with qualified leads
and career professionals
Post a job today
Jacqueline Moran
RECRUITMENT MARKETING ADVISOR
(800) 225-4569, ext. 2762
jmoran@advanstar.com
★
★
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January 2012
|
Marketplace
DermatologyTimes.com
RECRUITMENT
LOUISIANA
OHIO
DERMATOLOGY
DEPARTMENT CHAIR & STAFF
OPPORTUNITIES
Ochsner Health System is seeNing Board &ertiÀedBoard (ligiEle 0edical
Dermatologists for its Baton Rouge and North Shore Regions. 6ubspecialty training and
or interest is Zelcomed but not reTuired.
B$7ON RO8*(
DeSartment Head of Dermatology
Staff Dermatologist
NOR7H SHOR(
Staff Dermatologist
Ochsner Health System is a physician-led, non-profit, academic, multi-specialty healthcare
delivery system dedicated to patient care, research, and education. 7he system includes eight
hospitals and 3 health centers throughout 6outheast /ouisiana. 2chsner employs over 00
physicians representing all maMor medical specialties and subspecialties. We conduct over
300 ongoing clinical research trials annually. We offer a generous and comprehensive benefits
pacNage. We also enMoy the advantage of practicing in a favorable malpractice environment in
/ouisiana. 3lease visit our Zebsite, ZZZ.ochsner.org.
Baton Rouge, the state capital, represents the best of /ouisianaᅣs vibrant culture. 7he
community provides numerous cultural, educational, historical, and recreational activities and
is NnoZn for friendly people and uniTue food. 7he %aton 5ouge metropolitan area has a
population of ,000 and is home to /ouisiana 6tate 8niversity and 6outhern 8niversity.
7he North Shore is located across /aNe 3ontchartrain from 1eZ 2rleans. 7hese beautiful
suburbs offer sophisticated living in a family-oriented environment. 7his area provides
numerous cultural, historical, and recreational activities and has been ranNed as one of the
fastest groZing areas in the 8nited 6tates.
3lease email &9 to ochsnerShysiciancY#gmail.com
Ref. $DBRNS or call for more information. (O(.
Sorry no - Yisa oSSortunities aYailaEle.
NEW JERSEY
NEVADA
Dermatologist
MINDEN, NEVADA
General/Cosmetic/Surgical Dermatology
Medford, NJ (near Philadelphia, PA and
Cherry Hill, NJ). Brand new state of the art
office, fabulous opportunity, benefits offered.
FT/PT position available.
email inquiry or CV to:
Becky@accentderma.com
(Near South Lake Tahoe and Reno)
Bordered by the Spectacular Sierra Mountains
General/Cosmetic/Surgical Dermatology
FT/PT, BC/BE Associate Position
Opportunity for Partnership
e-mail: minderm@charter.net • Fax: 775-782-0500
Minden Dermatology
Suite 1, 1624 10th Street • Minden, NV 89423
NEW YORK
Part time/full time opportunity in lower manhattan
with single specialty dermatology group.
Professional patient population. We have MOHs
and all types of lasers on site to enhance your
experience. The ideal candidate will already be
enrolled with major managed care organizations.
Contact MARINA
At Goldman150@Verizon.net or 212-962-1115
REPEATING
an ad ensures it will be
seen and remembered.
Call Jacqueline Moran
to place your
Recruitment ad at
800.225.4569,
ext. 2762
jmoran@advanstar.com
UNIVERSAL
DERMATOLOGY
Universal Dermatology:
Excellent Opportunity with New Office in
Central Ohio. Professional management
through Ameriderm. FT or PT. Must be BC
or BE. Will teach cosmetics. 300K plus
starting for full time. If you are a dedicated
physician who wants to focus your skills on
patient care in Central Ohio... This is your
opportunity!.
Email CV to: gkrenitsky@gmail.com
OREGON
EUGENE, OREGON
Part Time/Full Time Position
General/Cosmetic/Surgical
Dermatology
Spectacular Scenic Beauty
Excellent Benefits
Fax CV & Cover Letter to
541-683-5206 Or Call 541-683-0878
PENNSYLVANIA
BC/BE Dermatologist
PENNSYLVANIA
Well-established, thriving practice
with 7 dermatologists seeks
BC/BE Dermatologist.
State of the art 12,000 sq. ft. new facility with
in-house Mohs, dermatopathology, aesthetic
services, lasers and phototherapy. Excellent
benefits, malpractice, health insurance, vacation/
CME. Partner buy-in after 2 years. Located in
a rapidly-growing, affluent, family-oriented
community with a population of 519K.
Call Bonnie Oberholtzer at
(717) 509-5968
or e-mail to: blo@dermlanc.com
Together, we can save a life
1-800-GIVELIFE • www.redcross.org
American
Red Cross
67
68
Dermatology Times |
January 2012
physician’s profile
Susan Nedorost, M.D.
Born:
Cincinnati
Medical degree:
Case Western Reserve University,
Cleveland
Internship:
Cleveland Clinic Foundation
Residency:
Cleveland Clinic Foundation
Hobbies:
Decorating her urban townhouse; taking
care of her two Havanese dogs; growing
and cooking with herbs; playing tennis.
Family:
Husband Bob Nedorost, an engineer; two
daughters in their 20s.
The eczema team includes: back row (from left), Eli Silver, M.D.; Nicole Lidyard, R.D.; Mary
C. Smith, R.N., C.N.S.; front row (from left), Joan E. Tamburro, D.O.; Susan T. Nedorost,
M.D. (Photos: Susan T. Nedorost, M.D.)
In Her Own Words:
What is the best professional advice you ever
received?
Dr. Nedorost: “Listen and consider. Don’t feel like you
have to act right away.”
Breaking barriers
Cleveland derm uses power of teamwork to tackle eczema challenges
By Lisette Hilton
Staff Correspondent
S
usan T. Nedorost, M.D., is on
a mission to change what she
says is a problem for patients
plagued by eczema.
“Dermatitis has been the poor stepsister
to psoriasis,” Dr. Nedorost says. “Now, I
think it’s going to get the attention that it
deserves because the burden of disease is
just as great as psoriasis.”
Part of the solution, she says, is to offer
patients an interdisciplinary approach
to their care. So in 2010 she co-founded
the University Hospitals Interdisciplinary
Eczema Clinic in Cleveland.
Overcoming challenges
Several things work against dermatitis,
according to Dr. Nedorost. For one, healthcare providers vary in how they define the
term. “We did a survey and even dermatologists use it differently,” she says. “Some
define dermatitis as any inflammation of
the skin. And some people, like me, use it
to mean a very specific type of inflammation that is characterized by spongiosis
histologically, and by itching, oozing and
fissuring, clinically.”
Dermatitis often is multifactorial, says
Dr. Nedorost, who is associate professor
of dermatology and associate professor in
environmental health sciences, University
Hospitals Case Medical Center, Cleveland.
Because it’s harder to define the cohort,
dermatitis hasn’t gotten nearly the attention
in research that psoriasis has, she says.
The result? Eczema patients often get
different messages from different disciplines. That creates confusion and mistrust
of the healthcare system among those with
the disease, she says.
Working together
Dr. Nedorost helped to spearhead an
interdisciplinary eczema clinic, bringing
together dermatologists, allergists, a
psychologist, a dietician and a nurse practitioner. While there are several multidisciplinary models of care, few interdisciplinary
clinics are devoted to eczema, she says.
In a multidisciplinary clinic, patients might
have access to many disciplines, but the
specialists don’t necessarily work together
on patients’ care plans.
One of the biggest barriers, she says,
was for physicians from different disciplines
to learn how to work together. “Among
institutions, there really isn’t much faculty
development on teamwork, so we’ve had
to work on that on our own,” she says.
“But I do think that a team is always better
than an individual in caring for a patient.
We’re learning how to get the patient to the
providers that they need the most. Once we
achieve that, it will increase efficiency.”
Immunology interest
Dr. Nedorost says she went into dermatology because of her love for immunology.
“Contact dermatitis is my specialty focus,
and that’s immunology played out in the
skin. Being able to discern the subtypes of
dermatitis and providing patient education
at each step of the management process
can lead to really good outcomes.”
Dr. Nedorost, who has begun writing a
dermatitis monograph, has other big plans,
as well. As residency program director
in dermatology at University Hospitals
Case Medical Center, she wants to impact
residents by teaching frugality of care. “My
legacy is to help redesign healthcare practices … so that we better teach physicians
how to really think through everything on
an individual level. I honestly think that will
decrease cost of care.” DT
Learn more!
For more information about Dr. Nedorost’s
eczema clinic, visit www.dermatologytimes.
com/interdisciplinaryefforts.
BRIEF SUMMARY
VELTIN™ (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
The following is a brief summary only; see full prescribing information for complete
product information.
INDICATIONS AND USAGE
VELTIN Gel is indicated for the topical treatment of acne vulgaris in patients
12 years or older.
CONTRAINDICATIONS
VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis,
or history of antibiotic-associated colitis.
WARNINGS AND PRECAUTIONS
Colitis
Systemic absorption of clindamycin has been demonstrated following topical use.
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have
been reported with the use of topical clindamycin. If significant diarrhea occurs,
VELTIN Gel should be discontinued.
Severe colitis has occurred following oral or parenteral administration of clindamycin
with an onset of up to several weeks following cessation of therapy. Antiperistaltic
agents such as opiates and diphenoxylate with atropine may prolong and/or worsen
severe colitis. Severe colitis may result in death.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibioticassociated colitis.
Ultraviolet Light and Environmental Exposure
Exposure to sunlight, including sunlamps, should be avoided during the use of
VELTIN Gel, and patients with sunburn should be advised not to use the product
until fully recovered because of heightened susceptibility to sunlight as a result
of the use of tretinoin. Patients who may be required to have considerable sun
exposure due to occupation and those with inherent sensitivity to the sun should
exercise particular caution. Daily use of sunscreen products and protective apparel
(e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may
be irritating to patients under treatment with VELTIN Gel.
ADVERSE REACTIONS
Adverse Reactions in Clinical Studies
The safety data reflect exposure to VELTIN Gel in 1,104 patients with acne vulgaris.
Patients were 12 years or older and were treated once daily in the evening for
12 weeks. Observed local treatment-related adverse reactions (≥1%) in clinical
studies with VELTIN Gel were application site reactions, including dryness (6%),
irritation (5%), exfoliation (5%), erythema (4%), pruritus (2%), and dermatitis (1%).
Sunburn (1%) was also reported. Incidence of skin reactions peaked at week 2
and then gradually decreased.
Local skin reactions were actively assessed at baseline and at the end of 12 weeks
of treatment in patients exposed to VELTIN Gel. At baseline (N=476), local skin
reactions included erythema (24%), scaling (8%), dryness (11%), burning (8%),
and itching (17%). At 12 weeks of treatment (N=409), local skin reactions included
erythema (21%), scaling (19%), dryness (22%), burning (13%), and itching (15%).
During the 12 weeks of treatment, each local skin reaction peaked at week 2 and
gradually reduced thereafter.
DRUG INTERACTIONS
Erythromycin
VELTIN Gel should not be used in combination with erythromycin-containing products
due to possible antagonism to the clindamycin component. In vitro studies have
shown antagonism between these 2 antimicrobials. The clinical significance of this
in vitro antagonism is not known.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Therefore, VELTIN Gel
should be used with caution in patients receiving such agents.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C. There are no well-controlled studies in pregnant women
treated with VELTIN Gel. VELTIN Gel should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. A limit teratology study
performed in Sprague Dawley rats treated topically with VELTIN Gel or 0.025%
tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result
in teratogenic effects. Although no systemic levels of tretinoin were detected,
craniofacial and heart abnormalities were described in drug-treated groups.
These abnormalities are consistent with retinoid effects and occurred at 16 times
the recommended clinical dose assuming 100% absorption and based on body
surface area comparison. For purposes of comparison of the animal exposure to
human exposure, the recommended clinical dose is defined as 1 g of VELTIN Gel
applied daily to a 50 kg person.
Tretinoin: Oral tretinoin has been shown to be teratogenic in mice, rats, hamsters,
rabbits, and primates. It was teratogenic and fetotoxic in Wistar rats when given
orally at doses greater than 1 mg/kg/day (32 times the recommended clinical dose
based on body surface area comparison). However, variations in teratogenic doses
among various strains of rats have been reported. In the cynomologous monkey,
a species in which tretinoin metabolism is closer to humans than in other species
examined, fetal malformations were reported at oral doses of 10 mg/kg/day or
greater, but none were observed at 5 mg/kg/day (324 times the recommended
clinical dose based on body surface area comparison), although increased skeletal
variations were observed at all doses. Dose-related teratogenic effects and
increased abortion rates were reported in pigtail macaques.
With widespread use of any drug, a small number of birth defect reports associated
temporally with the administration of the drug would be expected by chance
alone. Thirty cases of temporally associated congenital malformations have been
reported during two decades of clinical use of another formulation of topical
tretinoin. Although no definite pattern of teratogenicity and no causal association
have been established from these cases, 5 of the reports describe the rare birth
defect category, holoprosencephaly (defects associated with incomplete midline
development of the forebrain). The significance of these spontaneous reports in
terms of risk to fetus is not known.
Nursing Mothers
It is not known whether clindamycin is excreted in human milk following use of
VELTIN Gel. However, orally and parenterally administered clindamycin has been
reported to appear in breast milk. Because of the potential for serious adverse
reactions in nursing infants, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug
to the mother. It is not known whether tretinoin is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when VELTIN
Gel is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of VELTIN Gel in pediatric patients below the age of
12 years have not been established. Clinical trials of VELTIN Gel included 2,086
patients 12-17 years of age with acne vulgaris. [See Clinical Studies (14) of full
prescribing information.]
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic
potential of VELTIN Gel or the effect of VELTIN Gel on fertility. VELTIN Gel was
negative for mutagenic potential when evaluated in an in vitro Ames Salmonella
reversion assay. VELTIN Gel was equivocal for clastogenic potential in the absence
of metabolic activation when tested in an in vitro chromosomal aberration assay.
Clindamycin: Once daily dermal administration of 1% clindamycin as clindamycin
phosphate in the VELTIN Gel vehicle (32 mg/kg/day, 13 times the recommended
clinical dose based on body surface area comparison) to mice for up to 2 years did
not produce evidence of tumorigenicity.
Tretinoin: In two independent mouse studies where tretinoin was administered
topically (0.025% or 0.1%) three times per week for up to two years no
carcinogenicity was observed, with maximum effects of dermal amyloidosis.
However, in a dermal carcinogenicity study in mice, tretinoin applied at a dose
of 5.1 μg (1.4 times the recommended clinical dose based on body surface area
comparison) three times per week for 20 weeks acted as a weak promoter of skin
tumor formation following a single application of dimethylbenz[]anthracene (DMBA).
In a study in female SENCAR mice, papillomas were induced by topical exposure
to DMBA followed by promotion with 12-O-tetradecanoyl-phorbol 13-acetate or
mezerein for up to 20 weeks. Topical application of tretinoin prior to each application
of promoting agent resulted in a reduction in the number of papillomas per mouse.
However, papillomas resistant to topical tretinoin suppression were at higher risk for
pre-malignant progression.
Tretinoin has been shown to enhance photoco-carcinogenicity in properly performed
specific studies, employing concurrent or intercurrent exposure to tretinoin and
UV radiation. The photoco-carcinogenic potential of the clindamycin tretinoin
combination is unknown. Although the significance of these studies to humans is not
clear, patients should avoid exposure to sun.
PATIENT COUNSELING INFORMATION
[See FDA-approved Patient Labeling in full prescribing information.]
Instructions for Use
•
At bedtime, the face should be gently washed with a mild soap and water.
After patting the skin dry, apply VELTIN Gel as a thin layer over the entire affected
area (excluding the eyes and lips).
•
Patients should be advised not to use more than a pea sized amount to cover
the face and not to apply more often than once daily (at bedtime) as this will not
make for faster results and may increase irritation.
•
A sunscreen should be applied every morning and reapplied over the course
of the day as needed. Patients should be advised to avoid exposure to sunlight,
sunlamp, ultraviolet light, and other medicines that may increase sensitivity to
sunlight.
•
Other topical products with a strong drying effect, such as abrasive soaps or
cleansers, may cause an increase in skin irritation with VELTIN Gel.
Skin Irritation
VELTIN Gel may cause irritation such as erythema, scaling, itching, burning, or stinging.
Colitis
In the event a patient treated with VELTIN Gel experiences severe diarrhea or
gastrointestinal discomfort, VELTIN Gel should be discontinued and a physician
should be contacted.
VELTIN is a trademark of Astellas Pharma Europe B.V.
©2010 Stiefel Laboratories, Inc. VEL:2BRS July 2010
©2011 Stiefel Laboratories, Inc. All rights reserved. Printed in USA. VEL049R0 April 2011
VELTIN Gel—A Topical Treatment for Patients �� Years or Older With Acne Vulgaris
Once-daily application in the evening
VELTIN Gel
Combines the acne-fighting properties of tretinoin and clindamycin
Contains tretinoin, solubilized in an aqueous-based gel
Combats inflammatory and noninflammatory acne
Important Safety Information for VELTIN Gel
VELTIN Gel is contraindicated in patients with regional enteritis,
ulcerative colitis, or history of antibiotic-associated colitis
Systemic absorption of clindamycin has been demonstrated
following topical use. Diarrhea, bloody diarrhea, and colitis (including
pseudomembranous colitis) have been reported with the use of
topical clindamycin. VELTIN Gel should be discontinued if significant
diarrhea occurs. Severe colitis has occurred following oral or
parenteral clindamycin administration. Severe colitis may result
in death
Avoid exposure to sunlight and sunlamps when using VELTIN Gel.
Patients with sunburn should be advised not to use VELTIN Gel until
fully recovered. Daily use of sunscreen products and protective
apparel are recommended. Weather extremes (eg, wind and cold)
also may be irritating to patients using VELTIN Gel
Observed local treatment-related adverse reactions (≥�%) in clinical
studies with VELTIN Gel were application site reactions, including
dryness, irritation, exfoliation, erythema, pruritus, and dermatitis.
Sunburn was also reported. Incidence of actively assessed local skin
reactions peaked at week � and then gradually decreased
VELTIN Gel should not be used in combination with erythromycincontaining products due to possible antagonism to the clindamycin
component
Please see brief summary of Prescribing Information on the next page.
Clindamycin has been shown to have neuromuscular blocking
properties that may enhance the action of other neuromuscular
blocking agents. VELTIN Gel should be used with caution in
patients receiving such agents
VELTIN Gel should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus
It is not known whether either clindamycin or tretinoin is excreted
in human milk following use of VELTIN Gel. However, orally and
parenterally administered clindamycin has been reported to appear
in breast milk. Due to possible serious adverse reactions in nursing
infants, a decision should be made whether to discontinue
nursing or the drug. Exercise caution if administering VELTIN Gel
to a nursing woman
The efficacy and safety have not been established
in pediatric patients below the age of �� years
VELTIN Gel is not for oral, ophthalmic,
or intravaginal use