Introducing a complete regimen for seborrheic dermatitis

Transcription

New Promiseb Complete
TM
Introducing a complete regimen
for seborrheic dermatitis
• Includes new Promiseb PlusTM Scalp Wash
– Can be used on the scalp or body
– Fragrance free and cosmetically elegant
– Massage gently upon application to loosen
and wash away flakes
• Promiseb Complete Trial and Savings Program
– Initial prescription of Promiseb Complete
filled at no cost for eligible patients*
– Eligible patients will receive up to 5 refills
for no more than $20 each
*For a summary of all eligibility requirements please see back of rebate card available at www.promiseb.com
Promiseb® Topical Cream is a nonsteroidal prescription cream indicated to manage and relieve the signs and symptoms of seborrheic dermatitis
such as scaling, erythema, pruritus, and pain. Promiseb Topical Cream is contraindicated in persons with a known hypersensitivity to any
component of the formulation. Promiseb Topical Cream does not contain milk, wheat, peanut, or animal derivatives. Promiseb Topical Cream
does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oil
should consult their physician before using this topical preparation. Please see accompanying important safety information and full prescribing
information. The use of Promiseb Plus Scalp Wash is contraindicated for patients with a history of hypersensitivity to any of the ingredients.
For more information, please visit www.Promiseb.com.
Promiseb is a registered trademark of Promius Pharma, LLC.
©2012 Promius Pharma, LLC. All rights reserved. PSC-0412-081
For Topical Dermatological Use Only
For External Use Only
Rx only
Product Description:
Promiseb® Topical Cream is an off-white, steroid-free,
fragrance-free, water-based emulsion.
Indications for Use:
Under the supervision of a healthcare professional, Promiseb
Topical Cream is indicated to manage and relieve the signs
and symptoms of seborrhea and seborrheic dermatitis such as
itching, erythema, scaling and pain. Promiseb Topical Cream
helps to relieve dry waxy skin by maintaining a moist wound &
skin environment, which is beneficial to the healing process.
Directions for Use:
Apply Promiseb Topical Cream to the affected skin areas 2 to 3
times per day (or as needed), and massage gently into the skin.
If the skin is broken, cover Promiseb Topical Cream with
a dressing of choice.
Ingredients:
Promiseb Topical Cream is comprised of Purified Water,
Isohexadecane, Butyrospermum parkii, Pentylene glycol,
Ethylhexyl palmitate, Cera alba, PEG-30 Dipolyhydroxystearate,
Bisabolol, Polyglyceryl-6 polyricinoleate, Tocopheryl acetate,
Hydrogenated castor oil, Acifructol complex, Butylene
glycol, Magnesium sulfate, Piroctone olamine, Allantoin,
Magnesium stearate, Disodium EDTA, Vitis vinifera, Ascorbyl
tetraisopalmitate, Glycyrrhetinic acid, Propyl gallate, and
Telmesteine.
Caution:
The use of Promiseb Topical Cream is contraindicated in any
patient with a known history of hypersensitivity to any of the
ingredients. Promiseb Topical Cream does not contain milk,
wheat, peanut or animal derivatives. Promiseb Topical Cream
does contain shea butter (Butyrospermum parkii), a derivative
of shea nut oil (not peanut oil). Patients with a known allergy to
nuts or nut oils should consult their physician before using this
topical preparation.
How Supplied:
30 g tube, 67857-803-30
To Open: Puncture seal with pointed end of cap.
Important: The opening of this product is covered by a metal
seal. Do not use if seal has been punctured or is not visible.
Store at controlled room temperature 68° to 77°F (20° to 25°C),
excursions permitted between 59° and 86°F (15° and 30°C).
Distributed by Promius Pharma, LLC, Bridgewater, NJ 08807
Made in Italy
Federal law restricts this device to sale by or on the order of a
physician or properly licensed practitioner.
R 0209
150-210
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inside:
May 2012
teledermatology broadens
access to derms’ expertise;
still, barriers remain
May 2012 | Vol. 33, No. 5
clinical
dermatology
26
Careful laser selection, combos
standard for vascular treatment
cosmetic
dermatology
49
Gene-matched cosmetics:
Mostly hype, or practical?
Volume 33 No. 5
practice
mangement
56
Superior customer service
generates satisfied patients
special
report
skin
39
CanCer
Fine
tuning
Diagnosis
DistanCe
Driven by improving technology as well as undeniable need,
teledermatology continues to gain as a consultation option
By Lisette Hilton
Staff Correspondent
National report — Teledermatology just
got a boost: A new study shows that “remote
viewing” by skincare specialists improves the
accuracy of dermatologic diagnoses in the
primary care setting by almost 70 percent.
Some doctors predict this approach will
become an important part of virtual healthcare
in the future, offering increased access to the
specialty, lower costs, and flexibility and added
income for the practitioner.
“I think there is really no argument if you
talk to the experts in healthcare reform that
virtual health is going to have to be part of the
equation,” says Hon Pak, M.D., chief executive officer of the mobile technology company
Diversinet of Irving, Texas.
Still, many challenges — chief among them,
reimbursement — remain for the incorporation of this practice into mainstream medicine,
experts say.
Distant diagnosing: Reimbursement a hurdle See page 20
IL-17 inhibitors
may modify
approach
to psoriasis
By Paula Moyer
Staff Correspondent
International report —
Two experimental psoriasis
drugs that target the interleu k in (IL)-17 signa ling
pathway led to significant
improvements in skin lesions
for most patients over 12
week s, separate phase 2
studies show.
Inhibiting IL-17 may be
an effective approach for
managing psoriasis with
fewer of the immunosuppressive effects seen with
current biologic therapies,
results indicate.
Patients showed marked
improvements after treatment with the human monoclona l a nt ib ody brod alumab (Amgen) a nd t he
humanized IgG4 monoclonal antibody ixekizumab
(Eli Li l ly), according to
Fine tuning See page 24
magenta
cyan
yellow
black
dt0512_cv2.pgs 04.25.2012 17:29
ADVANSTAR_PDF/X-1a
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
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6
Editorial Advisory Board Update
Dermatology Times |
May 2012
insight & opinion
from our advisory board leaders
Norman Levine, M.D.,
in Tucson, Ariz.
Trust factors
How can you determine the validity and accuracy
of today’s published research?
I
n my early years in dermatology,
there were many distinguished
and acknowledged experts whose
published findings became part of
the core of the discipline. When they presented their findings at medical meetings
or in print, one assumed that the data was
valid and accurate, and it was often translated into specific management options for
our patients.
If future findings failed to support, or if
they actually refuted, these findings, it was
understood that science is a dynamic process in which improvements in research
methods, technology and evaluation of
data inevitably lead to advances, often at
the expense of what was previously considered to the “conventional wisdom.” In
fact, one of my medical school professors
claimed that 50 percent of what we would
learn in school would subsequently be
proven false. He was probably fairly accurate in his prediction.
The giants of
dermatology have largely
passed from the scene,
and a new generation of
real authorities has not
yet stepped forward.
With few exceptions, we seldom
questioned the intellectual integrity of
the researching dermatologists, many of
whom were supported by government
grants or institutional funding. Although
there may have been some industry money
involved in research efforts, one did not
get the impression that the work was being
overly influenced by those who supported
it financially. Rarely was one left with the
impression that there was intentional bias
in the published reports.
Times have changed. We are now in
the era of speakers bureaus, “thought
leaders,” hired guns with nominal academic credentials, and ghostwritten
research articles originating from the
offices of the pharmaceutical industry.
The giants of dermatology have largely
passed from the scene, and a new generation of real authorities has not yet stepped
forward. The truly independent clinical
researcher is harder to identify, since
many academic dermatologists have
consulting agreements with industry. Does
this compromise their independence and
standing in the academic community? In
my opinion, the answer is yes.
Sorting it out
There are scientific advances being
reported almost daily. How can we determine what is legitimate and what may be
over-hyped, biased information? If we can’t
trust the “experts,” can we rely on the opinions of bloggers or those who contribute to
online chat groups? Can we rely on those
who critically review the work of others?
Although admittedly over-simplified,
the following is a guide to the evaluation of
what you read and hear:
▶ Do not trust data reported by investigators under contract to entities with a
vested interest in the outcome of the work. I
will often avoid reading any article in which
one or more of the authors is an employee
of a company specifically interested in the
product or technology being discussed.
Even if the data is valid, the manuscripts are
often written with the intent of promoting a
point of view rather than giving a balanced
discussion of the data.
▶ Never take at face value information
presented at dinner meetings or similar
events by an individual who is a member
of a speakers bureau, and hence usually
sponsored by industry. I do not care how
insistent the claim is made that the speaker
is free to say what he pleases about the
subject being discussed. I can assure you
that the sponsor will not tolerate negative
comments about its products.
▶ Online chat groups are a nice way
to communicate with colleagues. However, the information is totally unfiltered,
notoriously anecdotal in nature, and often
unreliable. Be careful before deciding on
management options based on the comments in these forums.
▶ You are reading this editorial in a news
magazine and thus have some inclination
that this form of communication is valuable
to you. Many of the articles represent the
work of skilled reporters. However, these
reporters must rely on the veracity and
knowledge of others who may have an
agenda to be promoted. Be wary of this
information and try to find other published
documents to support the claims of these
individuals.
▶ There are several excellent dermatology journals, and there are numerous
ones of lesser quality. Good editors make a
difference in what gets published. I tend to
trust articles published in Journal of Investigative Dermatology, Archives of Dermatology, Journal of the American Academy of
Dermatology and British Journal of Dermatology over others in our specialty.
▶ There are publications that review and
comment on published articles in the dermatology literature. I find these extremely
valuable resources since the reviewers are
well informed and are completely unbiased
in their opinions. Two such publications are
Journal Watch and DermClips.
There’s voluminous new information
appearing in the rapidly changing scientific community, but we must avoid the
pitfall of believing everything that we read
or hear. DT
Norman Levine, M.D.
Questions? Comments? Email the
editor at astankiewicz@advanstar.com.
aquapharm.com
MAD-1102
8
legal eagle
Dermatology Times
|
May 2012
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.
Conflict resolution
When the board of nursing and board of medical examiners
disagree, who wins?
D
r. Laser has a large cosmetic
dermatology practice in a
highly regulated state. As
a general rule, he and his
fellow physicians perform most of the
laser procedures in his office.
With the onset of the recession,
however, many of his patients are no
longer able to afford his office fees. In an
attempt to lower his fees, Dr. Laser spent
an enormous amount of time teaching
his nurses to use lasers for various problems such as hair removal, facial toning
and acne treatment.
In several states, there
are even conflicts
between the board
of nursing (with
jurisdiction over nurses)
and the board of
medicine (with
jurisdiction over
physicians).
Dr. Laser sent his staff to many training
courses and established rigid in-office
guidelines for laser treatments. Not only
did the staff become expert at treatment
protocols, they also became adept at
providing expert informed consent and
lessening the incidence of complications. Dr. Laser was comfortable that his
nonphysician providers were as good
as, or better than, some physicians
performing similar treatments.
Unfortunately, one of Dr. Laser’s
patients who was treated by a laser nurse
(without any physician present at the time
of the incident) now has a scar on her
upper lip. The patient was given appropriate consent, and the utilized technique
was appropriate. The patient, however,
immediately sought legal counsel. The
plaintiff patient’s attorney had the medical
records evaluated by two experts in the
field, and no breach in the standard of
care could be found. No negligence was
present. No lawsuit was filed in court.
Not being satisfied, the patient filed
a complaint against the nurse and Dr.
Laser with the state board of nursing. The
substance of her complaint was that a
nurse can never be as “good” as a physician, and therefore, Dr. Laser and his
nurse should be sanctioned.
Of course, the board of nursing has
no jurisdiction over Dr. Laser, who like all
physicians was licensed by and comes
under the jurisdiction of his state board
of medical examiners. The state board
of nursing has administrative regulations that allow nurses to perform laser
treatments. Dr. Lasers’ nurse is not sanctioned by the state board of nursing.
The aggrieved plaintiff patient then
filed a complaint against Dr. Laser with
his state board of medical examiners.
Her contention was that treatment in a
medical office is the practice of medicine
and therefore cannot be delegated to a
nurse. She sought sanctions against Dr.
Laser. The state board administrative
regulations do state that laser treatment
is considered the practice of medicine;
however, the regulations do not specifically address the delegation of treatment
to nurses.
The aggrieved plaintiff wants Dr.
Laser’s license revoked. Should Dr.
Laser be worried?
Eye on Kentucky
There is no easy answer to this issue.
Regulations vary from state to state. In
several states, there are even conflicts
between the board of nursing (with
jurisdiction over nurses) and the board
of medicine (with jurisdiction over physicians). Kentucky is one such example.
Kentucky’s legislature has enacted
statutes that define both the practice of
medicine and the practice of nursing.
The statutes are completely silent with
respect to cosmetic laser procedures.
This silence creates a problem. The
statute’s silence means that both the
medical and nursing boards have leeway
in interpreting the law for themselves.
The Kentucky Board of Medical Licensure asserts that the ultimate supervisor
for laser procedures must be a physician; the nursing board disagrees and
says that an advanced registered nurse
can also supervise such procedures. In
addition, the Kentucky Medical Board
adopted a position statement holding
that all laser procedures, including laser
hair removal and intense pulsed light,
constitute the practice of medicine and
must therefore be performed only under
the supervision of a physician.
In 2004, the Kentucky Medical Board,
in request to a request for an opinion
on laser hair removal by nurses, stated
that the procedure was within the scope
of nursing practice but that the Medical
Board would require nurses to have
medical supervision.
Meanwhile, Kentucky’s nursing board
published a 2008 advisory opinion in
which it stated that laser treatments,
including nonablative lasers, laser skin
resurfacing, intense pulsed light and
laser hair removal, are all included within
the scope of nursing practice. The confusion between the medical board and
nursing board in this state and others
becomes obvious.
Unfortunately, depending on his jurisdictional rules, Dr. Laser may need to hire
his own health law attorney to sort out the
issues in this case. DT
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on call
10
Dermatology Times
|
May 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.
Bracing for change
Uncertain future for healthcare prompts derms
to expand, adjust services
A
fter a two-month extension,
Congress, once again,
postponed scheduled
Medicare reimbursement
cuts, at least until the end of the year. The
Affordable Care Act ended up before the
U.S. Supreme Court with the ruling on its
constitutionality — either in total or in part
— expected in June.
“After three years of
trying to lean out the
practice, I think it’s
matured to the point
where we don’t want to
become any more lean
in terms of office staff.”
Christopher Dannaker, D.O.
University of California, San Francisco
Dr. Wray
What’s more, November’s presidential
and congressional elections could change
the direction of the country. On Call asked
dermatologists around the country what
they, or their practices, are planning this
year as they await a determination of what
healthcare delivery will look like. Are they
making any major changes, expanding or
downsizing their practices?
Adam Wray, D.O., is a hospitalemployed dermatologist in Blackfoot,
Idaho. He says the hospital is positioned
fairly well at this point and isn’t planning any
major moves.
“I think everybody’s concerned about
expanding; nobody’s really optimistic
about what the future holds, both for healthcare and the economy, in general. We’re
just taking a wait-and-see approach.
“The advantage we have is that it’s a
critical access hospital. Whether it’s real or
just perceived, I think there is some protection from major changes in the healthcare
system, because of the hospital being
critical access for Medicare,” he says.
In practice for five years and on the
clinical faculty for Pacific Northwest University and Idaho State, Dr. Wray says that at
this point in his career, it’s nice to have that
kind of security.
“Had I not been married and had kids,
I possibly would have gone out on my
own. The challenge of running a practice is
something that interests me, but when you
have medical school loans to pay off, and
mouths to feed, that security is important.”
Out-of-pocket only
In Monterey, Calif., Christopher Dannaker,
D.O., has positioned himself so he is insulated from what the government will do
about healthcare. Seven years ago he transitioned to a totally cosmetic practice, and
he doesn’t accept Medicare or any other
insurance.
“I opted out of Medicare so as not to
create any positive dissonance between
a patient receiving treatment then trying
to file for Medicare. By opting out, we can
perform cosmetic services without concern
about whether or not Medicare would
deem it to be noncosmetic.”
Dr. Dannaker, assistant professor at
the University of California, San Francisco,
thinks his practice may have seen some of
its more difficult times in the past few years.
“Cosmetic dermatologists did get hit
when the economy fell. I also faced another
difficulty because new competition developed around here from noncore specialists, and even RNs.
“But over the last couple of years,
despite the economic recession, our business started to pick up because many
patients who had services from those
paramedical and noncore specialists have
become dissatisfied, at least in our small
community. Therefore, after a few years,
they’ve actually came back to our practice.”
Dr. Dannaker says he thinks he is well
prepared for what comes next because of
actions he’s taken over the past few years.
“After three years of trying to lean out
the practice, I think it’s matured to the point
where we don’t want to become any more
lean in terms of office staff. My economizing
moves have probably already occurred.
“Now we are looking at the acquisition
of new capital equipment very carefully.
We don’t try to amortize our costs over
a long period, even five-year leases. We
want that technology to pay for itself in a
much shorter lifespan, because we can’t
be fully confident of what patient desires
for that technology will be in the future,” Dr.
Dannaker says.
A decision to sell older equipment
shortly before the economy tanked worked
out well for Dr. Dannaker’s practice, he
says.
“I’m a solo practitioner with seven
lasers, so I do have a lot of technology. I
made my purchases before the economic
downturn. Then, at the beginning of the
downturn, I purged and sold all of my older
lasers that I felt were redundant or not
as useful. If I had waited, those would be
unsellable now,” he says.
Expanding operations
Other dermatologists are taking an active
approach to this year’s instability. In
Bluffton, S.C., Carmen Traywick, M.D., in
practice for less than three years, recently
bought another solo practice.
“We had been discussing it for a year
and a half, but didn’t want to commit
because of the uncertainty. We were going
back and forth. We’ve needed to expand
for a while but the uncertainty held things
up. We finally ended up buying the practice
assets and joining with the other dermatologist. We kind of had to do it now because
the other dermatologist didn’t want to take
on converting to electronic medical records
(EMRs) and wanted to slow down a bit. We
May 2012
|
already had EMR, and it was such a great opportunity, we couldn’t
let it pass,” Dr. Traywick says.
The decision by Congress to yet again delay Medicare reimbursement cuts gave Dr. Traywick some financial
Dr. Traywick
breathing room, she says.
“When the Medicare cuts were postponed
again, we knew we would have this year to start
paying things off. It’s a good move,” Dr. Traywick
says. “Ideally I would like to build a bigger office and
actually own the building, but at least this is bridging
the gap so I have more space. It’s a little baby step.”
Despite wanting to expand, Dr. Traywick says
she probably wouldn’t have taken the step were not
for one other factor.
“I wouldn’t be here except for the fact my husband handles all
the business. He really wanted to open a business. This way, if he’s
opening a business and working long hours, at least it’s benefiting
both of us instead of some other company,” she says.
Meeting a need
In Cape Girardeau, Mo., solo practitioner Charles Moon, M.D., is
also expanding this year. “I just purchased land, and I’m starting the
design and building process on a new building. I’m looking not only
to expand the physical facility, but also our numbers,” he says.
Whatever happens on a national, or local basis, Dr. Moon says he
also believes this was something that he had to do. “I think dermatology is always going to be in demand,
Dr. Moon
regardless of how the healthcare market
fares. Right now there’s a lot of fat that could
be trimmed, and we would still do OK. I’m
saving as much as I can.”
Growing his practice will allow Dr. Moon
to operate more efficiently and to address a
demand for cosmetic services, he says. “By
expanding a little bit, I can be more efficient.
I’m less efficient in my space now because
it’s too small. It limits me in adding ancillary services. By growing, I
can control my overhead better by having a partner and having the
space for a partner. I plan to expand services into the cosmetic area,
because I’m limited there also.”
In practice for nine years, Dr. Moon spent several years in the military, one in a group practice, and 2 1/2 years solo.
“My area is really underserved. There’s a big demand for
cosmetic services that hasn’t been filled. We have a few plastic
surgeons to do invasive procedures, but they don’t do lasers,
other noninvasive procedures, or product lines, so there is room to
develop. The key is to develop ancillary services.
“If pathology gets hit, it’s not a big deal because I still do a lot of
general dermatology. If general derm gets hit, OK, I do little cosmetic
dermatology. If the economy dips again, I go back and do general
dermatology. They are just ways to hedge a little bit,” he says.
Dr. Moon says he anticipates demand for dermatologists to
rise as the draw of retirement pulls more physicians away from the
specialty.
“Dermatologists who specialize in Mohs surgery could be the
ones to worry, because I think Mohs codes are going to get whacked
big time, which is a shame because it’s a great thing. If I were 55 and
didn’t want to redevelop my practice, I would probably get out of
medicine. I think we will see an exodus of people who can retire, will
retire. So, the demand is only going to become stronger for dermatology services for the people who are practicing,” he says. DT
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*At 8 weeks, 77% of patients treated with Levulan PDT experienced 75% clearance of AK lesions vs
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lesions and 60% of the patients had 75% clearance of scalp lesions. 66% of patients treated with
Levulan PDT experienced 100% clearance of AK lesions vs 13% of the control group. 70% of the
patients treated with Levulan PDT had 100% clearance of face lesions and 55% of the patients
had 100% clearance of scalp lesions.
Important Risk Information
The Levulan® Kerastick® for Topical Solution plus blue light illumination using the BLU-U® Blue Light Photodynamic
Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.
Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria, or known
allergies to porphyrins, and in patients with known sensitivity to any of the components of the Levulan Kerastick
for Topical Solution.
The most common adverse events include scaling/crusting, hypo/hyperpigmentation, itching, stinging and/or burning,
erythema and edema. Severe stinging and/or burning at one or more lesions being treated was reported by at least
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Following treatment, the treated AKs and to some degree the surrounding skin may redden, and swelling and scaling
may also occur. However, these effects are temporary and should completely resolve by 4 weeks after treatment.
**Patients treated with Levulan PDT should avoid exposure
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14
Dermatology Times
|
May 2012
research stat
abstracts from that pile of peer-reviewed journals on your desk
Clinical Dermatology
◾ Dual moDe laser effective
for acne vulgaris treatment
Journal of the american academy of
Dermatology
april 2012
A dual mode 1,064 nm Nd:YAG laser rapidly and effectively treats acne vulgaris,
according to a study published in the
April issue of the Journal of the American
Academy of Dermatology.
Researchers with Seoul National
University College of Medicine, South
Korea, reviewed the results of 22 patients
who received three sessions of quasilong pulse and Q-switched Nd:YAG laser
treatments. The treatments were assisted
with topically applied carbon suspension
at two-week intervals in a randomized,
split-face manner.
On the laser-treated side, inflammatory acne lesions were reduced by
58.6 percent, but they were increased on
the nontreated side by 5 percent, investigators found. Noninflammatory acne
lesions were reduced by 52.4 percent on
the treated side. Patients reported mild
transient erythema that disappeared
within a few hours, but no severe adverse
reactions were reported.
“The histopathologic findings correlated well with the clinical acne grade and
treatment response. This novel laser treatment appears to be safe and effective for
acne treatment,” the study authors wrote.
http://www.eblue.org/article/S01909622(11)01012-7/abstract
◾ Psoriasis theraPies’
effectiveness variable
archives of Dermatology
april 2012
The use of psoriasis therapies in clinical
practice may not be as effective as what
has been reported in previous trials,
according to a report published in the
April issue of Archives of Dermatology.
Researchers with University of Pennsylvania Perelman School of Medicine,
Philadelphia, compared the effectiveness
of biologic systemic therapy, nonbiologic
systemic therapy and phototherapy to
treat psoriasis in 713 patients. The proportion of patients achieving clear or almost
clear ratings on the Physician Global
Assessment scale was 23.8 percent for
methotrexate, 47.7 percent for adalimumab, 34.2 percent for etanercept,
36.1 percent for ustekinumab and 27.6
percent for narrowband UVB.
In adjusted analyses, investigators
found, patients who received adalimumab, etanercept and ustekinumab
were more likely to have clear or almost
clear skin, versus patients receiving
methotrexate. Patients who received
phototherapy demonstrated no significant difference compared to those who
received methotrexate.
“Although relative differences in
objective response rates among therapies may exist, absolute differences
are small and may not be clinically
significant. Dosing of common therapies varied from trial recommendations,” the study authors wrote. “These
results provide novel benchmarks
emphasizing the critical importance
of studying effectiveness in real-world
practice.”
http://archderm.ama-assn.org/cgi/content/abstract/148/4/487
◾ methotrexate, azathioPrine
equally effective for eczema
british Journal of Dermatology
april 2012
Azathioprine and methotrexate may be
equally effective and safe for short-term
treatment of severe atopic eczema,
according to a critical appraisal published
in the April issue of the British Journal of
Dermatology.
The appraisal examined a study
conducted by researchers with University
of Amsterdam, who sought to compare
the efficacy and safety of methotrexate
with azathioprine in 42 adult patients with
severe atopic eczema. The single-blind,
parallel-group, randomized controlled
trial was conducted in a secondary care
setting in the Netherlands from July 2009
to December 2010.
Patients with severe atopic eczema
were randomly assigned in a 1:1 ratio to
receive methotrexate at doses of 10 mg
to 22.5 mg weekly, or azathioprine
1.5 mg/kg to 2.5 mg/kg-1 daily for 12
weeks, followed by 12 weeks of followup. The primary outcome was the mean
change in the SCORing of Atopic Dermatitis index (SCORAD).
At week 12, patients taking methotrexate had a relative reduction in
SCORAD of 42 ± 18 percent compared to
39 ± 25 percent in the azathioprine group.
The proportions of patients achieving
at least mild disease and reductions in
impact on quality of life and symptoms
were similar for both groups at weeks 12
and 24, researchers found. No serious
adverse events were reported in either
group.
http://onlinelibrary.wiley.com/doi/10.1111/
j.1365-2133.2012.10872.x/abstract
◾ S. aureuS iDentifieD in Patients
with atoPic keratoconJunctivitis
allergy
april 2012
Staphylococcus aureus (S. aureus) and
S. aureus-secreted enterotoxins (SE) are
often found in patients who have atopic
keratoconjunctivitis (AKC), according
to a study published online April 10 in
Allergy.
Investigators with Tsurumi University
School of Dental Medicine, Yokohama,
Japan, studied 18 patients with AKC,
nine patients with vernal keratoconjunctivitis (VKC), eight with seasonal allergic
conjunctivitis (SAC) and 10 healthy volunteers. The researchers performed slit
lamp examinations and collected scraped
samples from the upper tarsal conjunctiva, lower conjunctival sacs and the skin
around the eyelid margins.
S. aureus was significantly more
prevalent in patients with AKC than with
VKC, SAC and the healthy volunteers.
Superantigen genes (SAg) were found
in 11 patients. In severe types of ocular
allergic disease such as AKC and VKC,
SE was detected in six of 10 patients with
corneal ulcers and in two of 17 patients
without the ulcers, the researchers determined.
“In patients with AKC, S. aureus
and SE were detected more frequently
compared with other patients and healthy
volunteers, especially in association with
corneal ulceration suggesting a role of
SE,” the study authors concluded. “So
far, it is unknown whether SE leads to
tissue damage of the cornea by initiating
an immune response or has direct toxic
effects.”
http://onlinelibrary.wiley.com/doi/10.1111/
j.1398-9995.2012.02818.x/abstract
Skin Cancer
◾ activities, smoking imPact
lymPh noDe role in melanoma
Dermatology
february 2012
Smoking habits, sports activities and
physical workload impact the sonomorphologic aspects of peripheral lymph
nodes (LNs) in patients with cutaneous
melanoma, according to a study published in the February issue of the Journal
of the American Academy of Dermatology.
Investigators with the University of
Bonn, Germany, conducted a prospective study of 200 patients with a history
of invasive cutaneous melanoma to
analyze the influence of sporting activity,
physical workload, smoking habits, infections of the upper respiratory tract and
interferon alfa therapy on the number and
morphology of LNs, which were examined
with high-resolution ultrasound.
During follow-up visits for melanoma,
patients underwent ultrasound exams of
cervical, axillary and inguinal LN regions.
Patients active in sports were found to
have more LNs in inguinal regions, a
higher volume and a larger LN diameter.
Patients with hard physical workloads in
their occupations had significantly higher
volume of the biggest LN.
Compared with nonsmoking patients,
smokers had higher values in the total
quantity of LNs, in the greatest volume of
LN, and in the greatest diameter of LN in
the cervical regions. Other factors had
no significant influence on the LN parameters, investigators found.
Study authors noted the study population was too small to comment on influencing factors in more detail, “especially
the influences of different sporting activities or smoking habits.”
◾ immune Pathway inhibition
may trigger melanoma growth
science translational medicine
march 2012
Melanocyte expression of an immune
inhibitory molecule may be associated
with the presence of tumor-infiltrating
lymphocytes, according to a study published in March in Science Translational
Medicine.
Researchers at Johns Hopkins
Medical Institutions, Baltimore, seeking
to determine the association between
immune inhibitory molecule B7-H1 and
tumor-infiltrating lymphocytes (TILs),
examined the expression of the molecule
in melanocytes and in primary and metastatic melanomas. Of the B7-H1-positive
tumors, 98 percent were associated with
TILs, while 28 percent of B7-H1-negative
tumors were associated with the lymphocytes. The investigators discovered
B7-H1-positive melanocytes were “almost
always” localized immediately adjacent
to TILs.
Interferon-gamma, a primary inducer
of B7-H1 expression, was detected at the
interface of B7-H1-positive tumors and
TILS, while none was found in B7-H1negative tumors.
“Therefore, TILs may actually trigger
their own inhibition by secreting cytokines
that drive tumor B7-H1 expression,” the
study authors noted. Patients with B7-H1positive metastatic melanoma survived
significantly longer than patients with
B7-H1-negative metastatic melanoma,
researchers determined.
“Induction of the B70-H1/PD-1
pathway may represent an adaptive
immune resistance mechanism exerted
by tumor cells in response to endogenous
antitumor activity and may explain how
melanomas escape immune destruction
despite endogenous antitumor immune
responses,” the authors wrote.
http://stm.sciencemag.org/
content/4/127/127ra37
◾ basal cell carcinoma on ear
significantly more aggressive
Dermatology
may 2012
Basal cell carcinoma (BCC) on the ear is
more likely to be aggressive and is more
frequently found in men than in women,
according to a study published in the
May issue of the Journal of the American
Academy of Dermatology.
Researchers at the University of
California, San Francisco, analyzed a
2009 database for all BCCs biopsied
from the ear. They reviewed data points
including tumor subtype and risk level
for 100 BCCs on the ear and 100 on the
cheek. BCC on the ear was diagnosed
471 times, and 57 percent were high risk
compared with 38 percent on the cheek,
investigators found.
Men were more likely to have BCC
on the ear, at 79 percent compared to 53
percent on the cheek. BCC on the ear in
women was also more likely to be aggressive, at 57 percent.
“BCC on the ear presents as an
aggressive phenotype in the majority of
cases for both men and women, and it
occurs much more frequently in men,” the
authors wrote. “Knowledge of this information can help guide physicians and
ensure that these tumors are adequately
biopsied and treated.”
The study authors noted the data
was retrieved during a single year at the
institution, and there could be potential
regional bias. Additionally, many of the
specimens were reviewed in consultation
and could therefore represent a selected
bias, they wrote.
16
washington & you
Dermatology Times
|
May 2012
Bob Gatty, former congressional aide,
covers Washington for businesses
specializing in healthcare and related
issues. Contact him at
bob@gattyedits.com.
Pushing for repeal
Physician groups, House Republicans aim to strike down IPAB
R
epublicans apparently have
given themselves an important and potentially emotional
campaign issue designed to
appeal both to those on Medicare and
the physicians who treat them come the
November election.
On March 22, the GOPcontrolled U.S. House of
Representatives voted to
repeal the controversial
Independent Payment
Advisory Board (IPAB).
On March 22, the GOP-controlled U.S.
House of Representatives voted to repeal
the controversial Independent Payment
Advisory Board (IPAB), established by the
new healthcare law now being challenged
in the U.S. Supreme Court, and intended to
provide a mechanism to control increasing
Medicare costs.
That, of course, has been sought by
large numbers of physicians groups,
including the American Academy of
Dermatology Association, which see
the IPAB as an unfettered entity whose
purpose will be to slash Medicare reimbursement rates for procedures and
services in order to reach pre-established
expenditure targets.
Such an action, opponents say, will ultimately lead to rationing of care.
Push and pull on IPAB
While Republicans in the Senate are
pushing for IPAB repeal, Democrats still
are in control there and are not expected
to support the measure, which President
Obama has promised to veto even if it
should pass.
The election-year strategy of House
Republicans became clear when they
included in the IPAB repeal legislation provisions that would limit medical
malpractice awards, also an objective of the
medical community, but strongly opposed
by many Democratic lawmakers.
While some observers speculated that
IPAB repeal might be supported by enough
moderate Democrats for it to squeak
through the Senate, adding the malpractice
caps only served to dilute that support
and virtually guarantee the issue will be
front and center during the fall campaign,
giving them the opportunity to reprise their
warning of a “death panel” making lifeand-death decisions regarding seniors.
Adding to the uncertainty for physicians is the question of how the Supreme
Court will rule on the challenge to the
healthcare law it is now considering.
Should the court rule the entire law is
unconstitutional, the IPAB will be history.
However, if the court upholds the law
or only tosses out specific provisions,
such as the requirement that individuals
must purchase health insurance or pay a
penalty, then the IPAB will remain.
Request for repeal
The AADA has urged its members to
contact lawmakers urging IPAB repeal,
joining other medical society members of
the IPAB Coalition that have been made this
a lobbying priority.
“This controversial, unelected board
has been granted unprecedented power
to replace congressional authority should
Medicare spending exceed its estimated
targets,” AADA said in a prepared statement. “Like the existing flawed SGR
(sustainable growth rate) formula, these
target-based expenditure systems fail to
contain Medicare costs and instead unfairly
place the cost-saving burden on physicians.”
Opponents of the IPAB make these
points:
▶ In its first five years, IPAB can only
recommend cuts in Medicare to physicians and a few other provider types.
However, hospitals, nursing homes, and
most other providers are exempt from
the cuts.
▶ Cuts are capped at 0.5 percent for
2015, 1 percent for 2016, 1.25 percent
for 2017 and 1.5 percent for 2018 and
beyond. Only a portion of Medicare
providers can be cut in the first five years,
however, so they will bear a large burden.
▶ IPAB cannot recommend increasing
Medicare premiums, co-pays or deductibles, and cannot recommend benefit
changes or eligibility restrictions.
▶ Recommended cuts must come from
within Medicare, not outside sources of
revenue.
▶ IPAB’s recommendations become law
each year unless Congress acts to overturn them or blocks or makes changes
and identifies alternative cuts within the
Medicare program.
In remarks on the Senate floor the
day the House approved the legislation,
Sen. Tom Coburn, M.D. (R-Okla.), a colon
cancer survivor, cautioned that one of the
first things that would be cut by the IPAB
would be the reimbursement rate for colonoscopies.
What would happen when the rate for
the procedure goes below costs, he asked.
“What do you think is going to happen on
screening?”
“What the American people need to
understand is what is coming about is a
group of 15 unelected bureaucrats who
cannot be challenged in court, who cannot
be challenged on the floor of the Senate
or House, mandating price reductions to
control the cost of Medicare,” he said.
“What does that actually mean? They
will do their job. We won’t be able to do
anything about it, but what it means is they
will reimburse at levels less than is the cost
to do services, and so consequently what
will happen is the service won’t be there.”
Dr. Coburn also pointed out that the
IPAB will be performing “comparative effectiveness research,” which, he contended,
will be used “to deny or change payments
for procedures that patients need.”
washington & you see page 18
Proven effective in moderate to severe acne* 1 ,2
Power
Now
with
ease!
in a ready-to-use
50g pump
●
Neat and simple: No jar, no mess
●
Measured dose: Consistent delivery
●
Longer shelf life: 10 weeks’ stability at room temperature
●
Convenience: Easily portable and meets TSA liquid carry-on limits
Indication and Important Safety Information
Acanya Gel is indicated for the topical treatment of acne vulgaris in patients
12 years of age or older. Acanya Gel is contraindicated in patients with a
history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Discontinuation is recommended if significant diarrhea, bloody diarrhea, severe
abdominal cramping, or colitis (including pseudomembranous colitis) develops.
Clindamycin taken orally or through IV may result in severe colitis, which may
result in death. Anaphylaxis, as well as other allergic reactions leading to
hospitalizations, has been reported in postmarketing use of products containing
clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic
reaction such as swelling or shortness of breath, they should be instructed
to discontinue use and contact a physician immediately. Patients should be
advised to avoid contact with the eyes or mucous membranes and to minimize
sun exposure following the application of Acanya Gel.
To learn more, please
visit www.AcanyaGel.com
Please see brief summary of prescribing
information on adjacent page.
You are encouraged to report negative side effects
of prescription drugs to the FDA. Visit www.fda.gov
/medwatch, or call 1-800-FDA-1088.
*Individual results may vary.
References: 1. Pivotal studies, data on file, CORIA Laboratories. 2. Gold M. A new,
once-daily, optimized, fixed combination of clindamycin phosphate 1.2% and lowconcentration benzoyl peroxide 2.5% gel for the treatment of moderate-to-severe acne.
J Clin Aesthetic Dermatol. 2009;2(5):44-48.
© 2012 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC ACAN-0112-0001
NOW IN A
PUMP
18
Dermatology Times
washington & you
washington & you from page 16
What’s wrong with all of this? Dr.
Coburn asked. “We are inserting a government board and government bureaucrat
between the patient and the doctor. Think
about that for a minute. When I go to my
doctor, I don’t want him concentrating
about anything except me. And if he’s
looking over his shoulder about whether or
not he met the IPAB’s comparative effectiveness study on what he’s doing for me
when, in fact, the art of medicine as well as
the science may say they’re wrong, and
he’s going to do what the government says
rather than what he thinks is best for me.
“The greatest threat for quality of care
for seniors in this country is the Independent Payment Advisory Board and their
noncaring position, because they’re going
to be looking at numbers and words, and
they’re never going to lay their hand on a
patient,” he adds. “They’re never going
|
May 2012
to impact a patient directly. They’re never
going to listen to a patient. But they’re going
to make the ultimate decisions based on
what that patient’s going to get.” DT
EDITOR’S NOTE: Mr. Gatty welcomes
dermatologists’ input about how governmental
policies, or pending policies, affect their practices. If you have a specific topic you’d like him to
explore in an upcoming issue, email him at
▶ bob@gattyedits.com.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C
There are no well-controlled trials in pregnant women treated with ACANYA Gel. It also is not known whether
ACANYA Gel can cause fetal harm when administered to a pregnant woman. ACANYA Gel should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
ACANYA®
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%
Brief summary. Please see full prescribing information for complete product information.
INDICATIONS AND USAGE
ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
The safety and efficacy of this product in the treatment of any other disorders have not been evaluated.
DOSAGE AND ADMINISTRATION
Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has
not been evaluated.
Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl
peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up
to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human
dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times
the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively)
revealed no evidence of teratogenicity.
Nursing Mothers: It is not known whether clindamycin is excreted in human milk after topical application
of ACANYA 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 use ACANYA Gel while nursing, taking into account the importance of the drug to the
mother.
ACANYA Gel is not for oral, ophthalmic, or intravaginal use.
Pediatric Use: Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not
been evaluated. Clinical trials of ACANYA Gel included patients 12-17 years of age.
CONTRAINDICATIONS
ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibioticassociated colitis.
Geriatric Use
Clinical studies of ACANYA Gel did not include sufficient numbers of patients aged 65 and older to
determine whether they respond differently from younger patients.
WARNINGS AND PRECAUTIONS
Colitis
Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea,
bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of
topical and systemic clindamycin. When significant diarrhea occurs, ACANYA Gel should be discontinued.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity and impairment of fertility testing of ACANYA Gel have not been performed.
Severe colitis has occurred following oral and 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 toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The
colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be
associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay
for C. difficile toxin may be helpful diagnostically.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate
to severe cases, consideration should be given to management with fl uids and electrolytes, protein
supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Ultraviolet Light and Environmental Exposure
Minimize sun exposure following drug application. (See NONCLINICAL TOXICOLOGY.)
ADVERSE REACTIONS
Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in
the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted
under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always
be directly compared to rates in the clinical trials of another drug. The adverse reaction information from
clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related
to drug use and for approximating rates.
The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA
Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).
During clinical trials, patients were assessed for local cutaneous signs and symptoms of erythema, scaling,
itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually
decreased over time reaching near baseline levels by week 12. The percentage of patients that had
symptoms present before treatment, the maximum value recorded during treatment, and the percent with
symptoms present at week 12 are shown below.
Local Skin Reactions—Percent Patients with Symptoms Present. Combined Results from the Two Phase
3 Trials (N = 773)
Erythema
Scaling
Itching
Burning
Stinging
Before Treatment (Baseline)
Mild
Mod*
Severe
22
4
0
8
<1
0
10
2
0
3
<1
0
2
<1
0
Maximum During Treatment
Mild
Mod*
Severe
25
5
<1
18
3
0
15
2
0
8
2
0
6
1
0
End of Treatment (Week 12)
Mild
Mod*
Severe
15
2
0
8
1
0
6
<1
0
2
<1
0
1
<1
0
Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal
studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for
20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.
Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5%
benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at
doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8,
and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA
Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with
a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and
2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin
site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in
rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times
amount of clindamycin and 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended
adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) for up to 97 weeks did not cause any
increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment
followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and
the number of tumors per mouse increased relative to controls following chronic concurrent topical
administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day,
5 days/week) and exposure to ultraviolet radiation.
Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl
peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic
in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in
Chinese hamster ovary cells.
Fertility studies have not been performed with ACANYA Gel or benzoyl peroxide, but fertility and mating
ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day
of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult
human dose of 2.5 g ACANYA Gel, based on mg/m2) revealed no effects on fertility or mating.
HOW SUPPLIED
ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50).
Dispensing instructions for the pharmacist
Dispense ACANYA Gel with a 10 week expiration date.
Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
Storage and Handling
PHARMACIST: Prior to dispensing, store in a refrigerator, 2°C to 8°C (36°F to 46°F).
PATIENT: Store at room temperature at or below 25°C (77°F).
Protect from freezing.
Keep out of the reach of children.
Keep container tightly closed.
*Mod=Moderate
RX Only
DRUG INTERACTIONS
Erythromycin
ACANYA Gel should not be used in combination with topical or oral erythromycin-containing products due to
its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin.
The clinical significance of this in vitro antagonism is not known.
Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America,
Fort Worth, TX 76107
Concomitant Topical Medications
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy
effect may occur, especially with the use of peeling, desquamating, or abrasive agents.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action
of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients
receiving such agents.
Manufactured by Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213
© 2010 CORIA Laboratories
May 2012
|
19
quick takes
news briefs
Getty Images/David DearPhotographer’s Choice RF
◾ finasteride labels change
Washington — The product labels
for finasteride are being changed to
warn patients about the potential for
sexual side effects that may linger even
after they stop taking the drug.
Merck’s Propecia (finasteride 1
mg) and Proscar (finasteride 5 mg)
had already been linked to sexual side
effects. The Food and Drug Administration expanded the warnings after
receiving reports of sexual disorders
that lasted for several weeks to several
months after discontinuation of the
drug, Medscape reports.
Propecia, used to treat male pattern
baldness, will now include warnings
about the potential for ejaculation,
libido and orgasm disorders. Proscar,
used to treat symptoms of enlarged
prostate, will warn patients about the
potential for decreased libido. Both of
the medications will also include warnings about the risk for male infertility
and poor semen quality, which normalized or improved after patients stopped
taking the drug.
patients. ICG was administered
intravenously and diode laser pulses
with different radiant exposures were
applied as a single treatment immediately afterward.
The patient and a blinded investigator evaluated safety and efficacy at
one and three months after treatment.
Reference therapy was treatment
with pulsed dye laser and diode laser
without ICG.
HealthDay News reports that the
safety of ICG application and diode
laser treatment were rated excellent
for all patients, with no persisting side
effects. Researchers found clearance
to be dose-dependent.
offThe Beat
Healing thyme: Herbal
tincture effective for acne
dublin — Herbal preparations containing thyme could be more effective for
treating acne than prescription creams, according to research presented at
the Society for General Microbiology’s recent Spring Conference.
Investigators from Leeds Metropolitan University tested the effects of
thyme, marigold and myrrh tinctures on Propionibacterium acnes and found
that while all three killed the bacterium in vitro after five minutes’ exposure,
◾ fda to rule on lyme testing
Washington — The Food and Drug
Administration is expected to soon
decide whether VGV-L, a drug candidate from Viral Genetics targeting
chronic Lyme disease, can move to
human trials.
PRWeb reports that company
researchers, working in conjunction
with various institutions, submitted a
pre-IND (Investigational New Drug)
briefing to the FDA, an early step toward
eventual clinical testing of the drug.
The pre-IND submission comes
after more than two years of testing. A
protocol for a human clinical trial was
submitted in April to the FDA along with
test results.
◾ 70+ sPf sunscreens Protect
los angeles — Water-resistant
sunscreen with a sun protection factor
of 70 or greater can help to adequately
protect people against skin cancer
and photodamage, even when applied
sparingly, a new study suggests.
The study, published in the April
issue of the Journal of the American
Academy of Dermatology, cites the
use of sunscreen with a minimum sun
protection factor (SPF) of 70.
Researchers from Neutrogena and
other consumer companies measured
the effectiveness of six sunscreens
when applied in amounts typically used
by consumers. Volunteers applied the
sunscreens, with protection labeled
from 30 SPF to 100 SPF, in varying
densities to determine how well the
products shield skin against solar rays.
According to HealthDay News,
the study found the greatest benefits
came from sunscreen labeled 70 SPF
or greater, even at lower application
densities. Data also showed a linear
relationship between application
density and actual SPF.
◾ icg, lasers treats leg veins
regensburg, germany —
German researchers report that diode
laser therapy augmented with indocyanine green (ICG) results in good to
excellent clearance of telangiectatic leg
veins with no persisting side effects.
Investigators from University
Hospital Regensburg assessed the
safety and efficacy of ICG-augmented
diode laser therapy for the treatment
of telangiectatic leg veins in 15 female
◾ stem cells sParK hair groWth
tokyo — Transplanted hair follicles
derived from adult stem cells have
demonstrated normal hair cycles in
bald mice, according to a recent study
published in Nature Communications.
Researchers at Tokyo University
of Science bioengineered hair follicle
germ cells from adult epithelial stem
cells and dermal papilla cells. They
then implanted the bioengineered cells
into the skin of bald mice, resulting in
thyme was the most effective, according to Medical News Today. The effects
were measured against an alcohol control.
Researchers also found that thyme had a greater antibacterial effect than
standard concentrations of benzoyl peroxide, commonly used in anti-acne
creams. The initial findings indicate the need for further tests to determine
how such tinctures work, investigators say. DT
normal hair cycles and other signs of
normal function, including piloerection,
or goosebumps, Medical News Today
reports. Along with normal functioning,
the implanted hair follicles also developed the correct structures and made
the right connections with surrounding
tissue, according to the report.
Age, race, lesion location and area
of country for patient treatment were
significantly associated with MMS use,
the authors write. The highest proportion of MMS among Medicare patients
was in Georgia, at 45.1 percent, while
the lowest rate was in Louisiana, at 11.0
percent.
◾ medicare surgeries double
new york — The use of Mohs micrographic surgery to treat nonmelanoma
skin cancer among Medicare beneficiaries doubled from 2001 through
2006, a study published in the April
issue of Archives of Dermatology
reports.
Researchers reviewed a sample of
Medicare beneficiaries who received
surgical intervention to treat NMSC
from 2001 through 2006. About 36
percent of the reported 26,931 operations were MMS. The rate of MMS
doubled during this time, while the
rate of surgical excision increased
slightly.
HealthDay News reports that MMS
was used to treat about 15 percent
of total body lesions, and nearly half
of all facial lesions among Medicare
recipients.
◾ mystery sKin disease Kills 19
Quang ngai, vietnam — Fourteen
out of 26 blood samples from patients
with a mysterious skin disease in the
central province of Quang Ngai have
tested positive for the rickettsia virus,
which is transferred from animals to
people by lice or fleas, Viet Nam News
reports.
The disease has affected 172
people and killed 19 in the province’s
rural communes.
The provincial health department
has asked the province to provide
financial assistance to equip medical
facilities with blood filters and medications to treat affected patients.
The World Health Organization has
also said that it is ready to support the
Vietnamese government in containing
the disease, which was first reported
last year. DT
20
DT news
Dermatology Times |
May 2012
... From page 1
DistAnt DiAGnosinG
Reimbursement still a hurdle
Dr. Armstrong
Currently, there are 37 active teledermatology programs in the United States,
according to April W. Armstrong,
M.D., M.P.H., assistant professor of
dermatology and director of teledermatology at University of California Davis
Health System, Sacramento.
That’s down from 60 such programs
identified in a 2003 survey by the
American Telemedicine Association’s
Dermatology Special Interest Group.
However, the volume of dermatology
consults per site actually doubled
over that period, says Dr. Armstrong,
a member of the American Academy
of Dermatology’s Telemedicine Task
Force and an author of a 2011 survey
of telederm programs.
“Even t houg h we have fewer
programs, the programs that we do
have seem to provide a lot of telemedicine services,” she says.
The study, published in the January
issue of Archives of Dermatology,
gives high marks to teledermatology.
Reviewing primary care records, Dr.
Armstrong and colleagues found that
1,500 live interactive teledermatology
consultations resulted in changes in
diagnosis in 69.9 percent of patients
and changes in disease management
in 97.7 percent of patients.
“It is one of the few outcome studies
in the field,” Dr. Armstrong says.
Who is using it?
A broad spectrum of private practices,
healthcare organizations and the
government are already employing teledermatology, last year’s survey shows.
Teledermatology sites offer a range
of capabilities, including live interactive videoconferencing and the online
store-and-forward approach, with
which referring providers upload or
send images of patients’ skin problems in encrypted medical records.
Health maintenance organizations
in particular are embracing the capability, according to Dr. Armstrong.
“For example, Kaiser Permanente in southern California last year
provided over 6,000 (teledermatology)
consultations, and this year they’re
story highlights
◾ Teledermatology offers options
◾ Derms can provide consults
from workplace or from home
◾ Reimbursement remains limited;
training, image quality are issues
projected to provide about 10,000
consultations,” she says.
Teledermatology can help guide
primary care providers where local
dermatologists aren’t readily available.
The capability also can assist with
triaging patients into conventional
dermatology clinics and can provide
remote support to clinics staffed
by physician extenders with some
dermatology training, according to
Dennis H. Oh, M.D., Ph.D., associate
professor of dermatology, University
of California, San Francisco, and vice
chairman of the American Telemedicine Association’s Teledermatology
Special Interest Group.
Teledermatolog y a lso br i ngs
sophisticated dermatological expertise to rural areas — for example,
the Alaska Native Medical Center in
Anchorage, operates a well-established
program — and provides extensive
support to military personnel.
“Telederm is one of the most
successful telemedicine programs for
the Army,” says Dr. Pak, who served
28 years in the
Dr. Pak
Army, where he
designed, developed and implemented one of the
largest telederm
programs in the
country. He later
became president
of the American
Telemedicine Association.
With more than 40,000 cases
logged to date, the military uses teledermatology not only to support its
U.S. clinics but also to get fast answers
for providers caring for soldiers at war,
Dr. Pak says.
Teledermatology also benefits those
who have limited access to specialists
because of their occupations. One
example: the cruise ship industry.
University of Miami Miller School of
Medicine has contracted with Royal
Caribbean International to provide
teledermatology consults 24/7 to the
cruise line’s 20,000 crew members on
33 ships worldwide.
Why all the interest?
Dr. Armstrong says organizations and
providers are realizing that today’s
technology allows them to meet
consumer demands for quicker diagnoses and easier access to healthcare.
Dermatologists in private practice
who want more flexibility and less
overhead also see teledermatology as
a way to supplement income and stay
active in the specialty.
For example, Marc E. Goldyne,
M.D., Ph.D., clinical professor of
dermatology, University of California,
San Francisco,
Dr. Goldyne
has devoted his
career to teledermatology.
“I’ve seen
more than 4,000
consu lts over
the last 10 years,
and they can be
any thing from
skin cancer, including melanoma,
to psoriasis, to eczema to childhood
moles,” he says. “Any of the visible
skin conditions that you can find in a
textbook will be inclusive of the things
that we see in teledermatology.”
Dr. Goldyne, who is also staff
physician, San Francisco VA Medical
Center, and chairman of the American
Telemedicine Association’s Teledermatology Special Interest Group, says
he has the freedom to work from home
when consulting on cases that employ
store-and-forward technology. And
while he says he makes less in reimbursements for teledermatology than
for seeing patients face-to-face, he
notes that he doesn’t have the overhead
of having to pay staff or office rent.
Barriers to growth
Still, reimbursement remains the
biggest barrier preventing teledermaDistant see page 23
Getty Images/Nicholas Eveleigh/Digital Vision
Telederm landscape
NOW APPROVED!
For more information,
visit www.Erivedge.com
Indication
Erivedge™ (vismodegib) capsule is indicated for the treatment of adults with metastatic basal cell carcinoma,
or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for
surgery, and who are not candidates for radiation.
WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS
Erivedge (vismodegib) capsule can result in embryo-fetal death or severe birth defects. Erivedge is embryotoxic
and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other
irreversible malformations.
Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks.
Advise female patients of the need for contraception and advise male patients of the potential risk of
Erivedge exposure through semen.
Boxed Warning and Additional Important Safety Information
Embryo-Fetal Death and Severe Birth Defects
• Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action
• Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks.
Advise female patients of the need for contraception during and after treatment and advise male patients
of the potential risk of Erivedge exposure through semen
• Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their
female partner) may be pregnant
• Immediately report exposure to Erivedge during pregnancy and encourage women who may have been
exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge
pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555
Blood Donation
• Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months
after the last dose of Erivedge
Nursing Mothers
• Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking
into account the importance of the drug to the mother
Adverse Reactions
• The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue,
nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
• In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge
• Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6
patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%)
Please see Brief Summary of Prescribing Information on the following page.
© 2012 Genentech USA, Inc. All rights reserved. HED0000822700 Printed in USA.
Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced
BCC Patients (cont)
MedDRA Preferred Term
2
Metabolism and nutrition
disorders
Decreased appetite
Musculoskeletal and
connective tissue disorders
Muscle spasms
Arthralgias
Nervous system disorders
Dysgeusia
Ageusia
Skin and subcutaneous
tissue disorders
Alopecia
ERIVEDGE (vismodegib) capsule
Initial U.S. Approval: 2012
This is a brief summary of information about ERIVEDGE. Before
prescribing, please see full prescribing information.
WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS
ERIVEDGE (vismodegib) capsule can result in embryo-fetal death
or severe birth defects. ERIVEDGE is embryotoxic and teratogenic
in animals. Teratogenic effects included severe midline defects,
missing digits, and other irreversible malformations.
Verify pregnancy status prior to the initiation of ERIVEDGE. Advise
male and female patients of these risks. Advise female patients
of the need for contraception and advise male patients of the
potential risk of ERIVEDGE exposure through semen [see Warnings
and Precautions (5.1), Use in Specific Populations (8.1, 8.6)].
All aBCC1 Patients (N = 138)
All Grades 3
Grade 3 Grade 4
(%)
(%)
(%)
35 (25.4%)
3 (2.2%)
-
99 (71.7%)
22 (15.9%)
5 (3.6%)
1 (0.7%)
-
76 (55.1%)
15 (10.9%)
-
-
88 (63.8%)
-
-
1
1 INDICATIONS AND USAGE
ERIVEDGE capsule is indicated for the treatment of adults with
metastatic basal cell carcinoma, or with locally advanced basal
cell carcinoma that has recurred following surgery or who are not
candidates for surgery, and who are not candidates for radiation.
2 DOSAGE AND ADMINISTRATION
The recommended dose of ERIVEDGE is 150 mg taken orally once
daily until disease progression or until unacceptable toxicity [see
Clinical Studies (14)].
ERIVEDGE may be taken with or without food. Swallow capsules
whole. Do not open or crush capsules.
If a dose of ERIVEDGE is missed, do not make up that dose; resume
dosing with the next scheduled dose.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Death and Severe Birth Defects
ERIVEDGE capsules can cause fetal harm when administered to a
pregnant woman based on its mechanism of action. Vismodegib
is teratogenic, embryotoxic, and fetotoxic in rats at maternal
exposures lower than the human exposures at the recommended
dose of 150 mg/day. In rats, malformations included craniofacial
anomalies, open perineum, and absent or fused digits. Fetal
retardations and variations were also observed.
Verify pregnancy status prior to the initiation of ERIVEDGE. Advise
male and female patients of the risks of embryo-fetal death and
severe birth defects and the need for contraception during and after
treatment. Advise patients to contact their healthcare provider
immediately if they suspect they (or, for males, their female partner)
may be pregnant. Female and male patients of reproductive
potential should be counseled regarding pregnancy prevention
and planning. If ERIVEDGE is used during pregnancy or if a patient
becomes pregnant while taking (or for a male patient, if his female
partner is exposed to) ERIVEDGE, the patient should be apprised of
the potential hazard to the fetus. Report immediately exposure to
ERIVEDGE during pregnancy to the Genentech Adverse Event Line at
1-888-835-2555. Encourage women who may have been exposed to
ERIVEDGE during pregnancy, either directly or through seminal fluid,
to participate in the ERIVEDGE pregnancy pharmacovigilance program
by contacting the Genentech Adverse Event Line at 1-888-835-2555
[see Boxed Warning, Use in Specific Populations (8.1, 8.6)].
5.2 Blood Donation
Advise patients not to donate blood or blood products while receiving
ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
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 clinical practice.
ERIVEDGE capsule was administered as monotherapy at doses
≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging
or fixed single dose clinical trials enrolling a total of 138 patients
with advanced basal cell carcinoma (BCC). The median age of these
patients was 61 years (range 21 to 101), 100% were White (including
Hispanics), and 64% were male. The median duration of treatment
was approximately 10 months (305 days; range 0.7 to 36 months);
111 patients received ERIVEDGE for 6 months or longer.
The most common adverse reactions (≥ 10%) were muscle spasms,
alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased
appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).
Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced
BCC Patients
All aBCC1 Patients (N = 138)
MedDRA Preferred Term2
Gastrointestinal disorders
Nausea
Diarrhea
Constipation
Vomiting
General disorders and
administration site
conditions
Fatigue
Investigations
Weight loss
All Grades 3
(%)
Grade 3
(%)
Grade 4
(%)
42 (30.4%)
40 (29.0%)
29 (21.0%)
19 (13.8%)
1 (0.7%)
1 (0.7%)
-
-
55 (39.9%)
7 (5.1%)
1 (0.7%)
62 (44.9%)
10 (7.2%)
-
aBCC = Advanced Basal Cell Carcinoma.
MedDRA = Medical Dictionary for Regulatory Activities.
3
Grading according to NCI-CTCAE v3.0.
Amenorrhea:
In clinical trials, a total of 3 of 10 pre-menopausal women developed
amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology (13.1)].
Laboratory Abnormalities:
Treatment-emergent Grade 3 laboratory abnormalities observed in
clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2
patients (1%), and azotemia in 3 patients (2%).
2
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Vismodegib
Drugs that Inhibit or Induce Drug Metabolizing Enzymes
Vismodegib elimination involves multiple pathways. Vismodegib is
predominantly excreted as an unchanged drug. Several minor
metabolites are produced by multiple CYP enzymes. Although
vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition
is not predicted to alter vismodegib systemic exposure since similar
steady-state plasma vismodegib concentrations were observed in
patients in clinical trials concomitantly treated with CYP3A4 inducers
(i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly
treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole).
Drugs that Inhibit Drug Transport Systems
In vitro studies indicate that vismodegib is a substrate of the efflux
transporter P-glycoprotein (P-gp). When ERIVEDGE is coadministered
with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin,
azithromycin), systemic exposure of vismodegib and incidence of adverse
events of ERIVEDGE may be increased.
Drugs that Affect Gastric pH
Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors,
H2-receptor antagonists, and antacids) may alter the solubility of
vismodegib and reduce its bioavailability. However, no formal clinical
study has been conducted to evaluate the effect of gastric pH altering
agents on the systemic exposure of vismodegib. Increasing the dose
of ERIVEDGE when coadministered with such agents is not likely to
compensate for the loss of exposure. When ERIVEDGE is coadministered
with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic
exposure of vismodegib may be decreased and the effect on efficacy of
ERIVEDGE is unknown.
7.2 Effects of Vismodegib on Other Drugs
Results of a drug-drug interaction study conducted in cancer patients
demonstrated that the systemic exposure of rosiglitazone (a CYP2C8
substrate) or oral contraceptives (ethinyl estradiol and norethindrone)
is not altered when either drug is co-administered with vismodegib.
In vitro studies indicate that vismodegib is an inhibitor of CYP2C8,
CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not
induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category D
ERIVEDGE capsule can cause fetal harm when administered to
a pregnant female based on its mechanism of action. Vismodegib
is teratogenic in rats at doses corresponding to an exposure of
20% of the exposure at the recommended human dose (estimated
AUC 0-24hr steady-state exposure). In rats, malformations included
craniofacial anomalies, open perineum, and absent or fused digits.
Fetal retardations and variations were also observed. Vismodegib is
embryolethal in rats at exposures within the range achieved at the
recommended human dose. If ERIVEDGE is used during pregnancy,
or if the patient becomes pregnant while taking this drug, the patient
should be apprised of the potential hazard to the embryo or fetus.
Report immediately exposure to ERIVEDGE during pregnancy to the
Genentech Adverse Event Line at 1-888-835-2555. Encourage
women who may have been exposed to ERIVEDGE during pregnancy,
either directly or through seminal fluid, to participate in the ERIVEDGE
pregnancy pharmacovigilance program by contacting the Genentech
Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings
and Precautions (5.1)].
In an embryo-fetal developmental toxicity study, pregnant rats were
administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day
during the period of organogenesis. Pre- and post-implantation loss
were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times
the systemic exposure (AUC) in patients at the recommended human
dose), which included early resorption of 100% of the fetuses. A dose
of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the
recommended dose) resulted in malformations (including missing
and/or fused digits, open perineum and craniofacial anomalies) and
retardations or variations (including dilated renal pelvis, dilated ureter,
and incompletely or unossified sternal elements, centra of vertebrae,
or proximal phalanges and claws).
8.3 Nursing Mothers
It is not known whether vismodegib is excreted in human breast
milk. Because many drugs are excreted in human milk and because
of the potential for serious adverse reactions in nursing infants from
ERIVEDGE, 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.
8.4 Pediatric Use
The safety and effectiveness of ERIVEDGE capsule have not been
established in pediatric patients.
In repeat-dose toxicology studies in rats, administration of oral vismodegib
resulted in toxicities in bone and teeth. Effects on bone consisted
of closure of the epiphyseal growth plate when oral vismodegib was
administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times
the systemic exposure (AUC) in patients at the recommended human
dose). Abnormalities in growing incisor teeth (including degeneration/
necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp,
ossification of the root canal, and hemorrhage resulting in breakage or
loss of teeth) were observed after administration of oral vismodegib at
≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the
recommended human dose).
8.5 Geriatric Use
Clinical studies of ERIVEDGE capsule did not include sufficient numbers
of patients aged 65 and over to determine whether they respond
differently from younger patients.
8.6 Females of Reproductive Potential and Males
ERIVEDGE capsule can cause harm to the embryo or fetus when
administered during pregnancy. Counsel female and male patients
regarding pregnancy prevention and planning. Advise patients to
contact their healthcare provider immediately if they suspect they (or,
for males, their female partner) may be pregnant [see Boxed Warning,
Warnings and Precautions (5.1), Use in Specific Populations (8.1)]
Female patients
Determine pregnancy status within 7 days prior to initiation of treatment
in females of reproductive potential. For females with a negative
pregnancy test, initiate a highly effective form of contraception (failure
rate of less than 1%) prior to the first dose. Continue highly effective
contraception during therapy and for 7 months after the last dose of
ERIVEDGE. If a patient becomes pregnant while taking ERIVEDGE,
or during the 7 months after the last dose of treatment, report the
pregnancy to the Genentech Adverse Event Line at 1-888-835-2555.
Encourage pregnant females to participate in the ERIVEDGE pregnancy
pharmacovigilance program by calling the Genentech Adverse Event
Line at 1-888-835-2555. Counsel pregnant females about the
teratogenic risk to the fetus.
Amenorrhea has been observed in clinical trials in females of
reproductive potential. Reversibility of amenorrhea is unknown [see
Adverse Reactions (6), Nonclinical Toxicology (13.1)].
Male patients
Male patients should use condoms with spermicide, even after a
vasectomy, during sexual intercourse with female partners while
being treated with ERIVEDGE capsule and for 2 months after the last
dose to avoid exposing an embryo or fetus to vismodegib.
8.7 Hepatic Impairment
The safety and effectiveness of ERIVEDGE capsule have not been
established in patients with hepatic impairment [see Clinical
Pharmacology (12.3)].
8.8 Renal Impairment
The safety and effectiveness of ERIVEDGE capsule have not
been established in patients with renal impairment [see Clinical
Pharmacology (12.3)].
10 OVERDOSAGE
There is no information on overdosage in humans. In clinical trials,
ERIVEDGE capsule was administered at 540 mg orally once daily;
exposure did not increase between 150 mg and 540 mg daily.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
• Advise patients that ERIVEDGE exposure during pregnancy can
cause embryo-fetal death or severe birth defects.
• Instruct female patients of reproductive potential to use a highly
effective form of contraception (failure rate of less than 1%) while
taking ERIVEDGE and for at least 7 months after the last dose of
ERIVEDGE.
• Instruct all male patients, even those with prior vasectomy, to use
condoms with spermicide, during sexual intercourse with female
partners while taking ERIVEDGE and for at least 2 months after the
last dose of ERIVEDGE.
• Instruct patients to immediately contact their healthcare provider
if they (or, for males, their female partner) become pregnant or if
pregnancy is suspected following exposure to ERIVEDGE.
• Instruct patients to immediately report any pregnancy exposure to
ERIVEDGE and encourage participation in the ERIVEDGE pregnancy
pharmacovigilance program by calling the Genentech Adverse Event
Line at 1-888-835-2555.
• Inform female patients of the potential for serious adverse
reactions in nursing infants from ERIVEDGE, taking into account the
importance of the drug to the mother.
• Advise patients not to donate blood or blood products while taking
ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE.
• Advise patients to swallow ERIVEDGE capsules whole and not to
crush or open the capsules.
ERIVEDGE™ [vismodegib] capsule
Manufactured by:
Patheon, Inc.
Mississauga, Canada
Distributed by:
Genentech USA, Inc.
ERIVEDGE is a registered trademark
A Member of the Roche Group
of Genentech, Inc.
©
2012 Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
1013 5 4 9 3
HED0000832300
May 2012
|
DT news
Distant from page 20
tology from reaching its full potential,
according to Anne E. Burdick, M.D.,
M.P.H., associate dean for telehealth
and clinical outreach and professor
of dermatology, University of Miami
Miller School of Medicine, Miami.
“There is limited reimbursement
by CMS (Centers for Medicare and
Medicaid Services) and private payers.
In some states, there are mandates for
all payers — private and government
— to pay for teleconsultations. But in
most of the states, including Florida,
state mandates do not exist,” she says.
Still, doctors or institutions have
found ways around the reimbursement
issue, such as contracting with groups,
organizations or businesses to provide
services.
Training is another barrier. Most
residency programs do not offer
practical experience or instruction
in teledermatology, according to Dr.
Armstrong.
“As a result, when dermatologists
go out into the workforce, they are
less likely to practice telemedicine,”
she says.
University of Missouri is among
the few medical schools and residency programs to include telehealth,
according to Karen E. Edison, M.D.,
Philip C. Anderson professor and
chairwoman, department of dermatology, and medical director, Missouri
Telehealth Network, University of
Missouri Health System, Columbia,
Mo. In dermatology, especially, the
program thrives, she says.
“We conduct two half-day teledermatology clinics weekly — one (in)
general dermatology, and one (in)
pediatric dermatology,” she says. The
program operates telehealth sites in
most rural counties throughout the
state of Missouri.
“In a single dermatology clinic,
we may care for patients in 20 or 30
locations,” Dr. Edison says. “Many
specialties use telehealth in our institution, but dermatology is one of the top
three users.”
Yet another issue holding telemedicine back is the quality of transmitted
images, even though it is improving,
according to Dr. Armstrong.
“I think there needs to be a greater
effort in terms of educating people
who do teledermatology,” she says.
“For example, the coordinator at the
referral site needs to know how to take
the photographs, so it gives us the best
chance to an accurate diagnosis.”
The upside
Doctors who use teledermatology
stand by its value. Not only does the
virtual consultation method improve
access, especially for patients in
rural areas and areas underserved by
dermatologists, but also it is convenient for providers and patients.
“Because we do teleconsultations …
I’m not traveling to different counties
to provide care,” Dr. Burdick says.
As for the research, most studies on
teledermatology have been encouraging regarding efficacy, according
to Dr. Oh.
A 2010 review of literature did
report that “Accuracy of teledermatology is inferior to in-person
dermatology care, especially for skin
malignancies,” but acknowledged
that “Little information exists on
the impact of teledermatology on
clinical outcomes” (Warshaw E, et
al., published January 2010 by the
Department of Veterans Affairs).
That review also found patient
and provider satisfaction with teledermatology to be “relatively high,
though there were individuals who
have strong beliefs for a particular
approach.”
Another potential benefit: Teledermatology also may help improve
primary care providers’ dermatology
knowledge because of the collaboration between dermatologists and
referring providers, according to Dr.
Burdick.
“I have seen (that) primary care
providers … have gotten an enhanced
knowledge base of skin disease and
treatment options,” she says.
Dr. Goldyne says, as far as he is
concerned, the quality of care possible
with teledermatology rivals that of an
in-person consultation.
“Having done store-and-forward
telemedicine now for about 10 years,
I feel as confident in making the
diagnosis as I do if the patient is in my
office,” he says.
In the rare cases where he isn’t sure,
he recommends that the patient visit a
dermatologist in person.
“I would say that might be three out
of 100 patients,” he says.
“In a single
dermatology clinic,
we may care for
patients in 20 or 30
locations.”
Karen E. Edison, M.D.
Medical director,
Missouri Telehealth Network
What about costs?
While dermatologists who practice
teledermatology say it is cost-effective, studies have yet to prove this.
Even a literature review published in
the January 2012 issue of the Journal
of Telemedicine and Telecare found
no conclusive evidence that telemedicine interventions are cost-effective
compared to conventional healthcare.
But Dr. Goldyne is convinced that
patients save money. For instance,
those who must travel hundreds of
miles to visit the nearest dermatologist
can save expenses such as gas, food and
sometimes even lodging, he says.
Dr. Armstrong says more studies
are needed to determine the costeffectiveness of teledermatology and
various telehealth interventions.
Tele take-home
Experts say access to quality care
will push teledermatology into the
mainstream.
“While in-person dermatology
may prov ide bet ter d ia g nost ic
and-or management accuracy when
compared with teledermatology, teledermatology is always better than no
dermatology,” Dr. Burdick says.
Dr. Pak says he sees widespread
adoption of teledermatology in the
next five to 10 years. Medicare and
Medicaid will get on board with telemedicine, he predicts, because of pressure from current healthcare reform
to increase access, provide evidencebased medicine and cut costs.
“This is all about reimbursement,”
Dr. Pak says. “Technology has been
proven. Outcomes studies have been
done. Standards have been developed.
Everything (is in place) but the reimbursement policy.” DT
23
24
DT news
Dermatology Times |
May 2012
... From page 1
Fine tuning: IL-17 blockade yields ‘high control’
studies published March 29 in the
New England Journal of Medicine
(2012;366(13):1181-1189 and 11901199, respectively). Both studies
were double-blinded and placebocontrolled.
“Both trials showed that patients
receiving the antibody had marked
improvements in the (Psoriasis Area
and Severity Index) PASI score,” wrote
Ari Waisman, Ph.D., in a commentary
editorial (1251-1252). Dr. Waisman
is professor of medicine, Institute
for Molecular Medicine, University
Medical Center at the Johannes-Gutenberg University of Mainz, Germany.
He added that the IL-17 approach
may address some of the concerns seen
with other biologic therapies such as
tumor necrosis factor (TNF) inhibitors.
While anti-TNF drugs have improved
treatment choices for patients with
autoimmune diseases, the need for
biologic agents that demonstrate “fewer
side effects and a milder effect on the
immune system” is clear, he wrote.
Brodalumab
The study on brodalumab involved
198 patients with baseline PASI scores
of at least 12 who were randomly
assigned to active therapy or placebo.
Patients on treatment were further
randomized to receive doses of
70 mg, 140 mg or 210 mg on the first day
of treatment and at weeks one, two, four,
six, eight and 10, or to receive 280 mg
monthly through the study’s duration.
By week 12, the average improvement was 45.9 percent for those on
70 mg, 85.9 percent for those on
140 mg, 86.3 percent for those on
210 mg, and 76.0 percent for those on
280 mg. The average improvement
for those on placebo was 16.0 percent
(p<0.001 for all treatment groups
compared to placebo). Investigators
story highlights
◾ IL-17 inhibitors show promise
for treatment of psoriasis
◾ Studies indicate targeting receptor
leads to “profound response”
◾ No serious side effects reported
saw a PASI improvement of 75 percent
in 77 percent of those on 140 mg and
82 percent of those on 210 mg, compared
to none on placebo.
The second study involved 142
patients on ixekizumab or placebo, with
patients on active treatment randomized to 10 mg, 25 mg, 75 mg or 150 mg
of ixekizumab at the study’s onset and
at weeks two, four, eight and 12. In that
study, investigators saw a PASI improvement of 75 percent in 76.7 percent of
those on 25 mg, 82.8 percent of those
on 75 mg, and 82.1 percent of those on
150 mg, compared to 7.7 percent of
patients on placebo (p<0.001 compared
to all treatment groups). These improvements persisted through a 20-week
follow-up period after treatment was
concluded.
In separate phone interviews with
Dermatology Times, the principal
investigators for
Dr. Papp
t he respec t ive
studies discussed
the results’ implications. Kim A.
Papp, M.D., Ph.D.,
led t he brodal u m a b s t u d y.
He is director of
research, Probity
Medical Research, a consortium of
clinical investigators in Waterloo,
Ontario, Canada. Craig Leonardi, M.D.,
who led the ixekizumab study, is clinical
professor of dermatology at Saint Louis
University School of Medicine in St.
Louis.
Breadth of response
A new look in the works…
You may have noticed some changes to the look of this
month’s Dermatology Times. We’re in the process of freshening our layouts in an effort to make the magazine easier
and more enjoyable to read! Of course, we’ll continue to
bring you the timely, compelling editorial content you need
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Amy Stankiewicz, Editor-in-Chief
“Our study shows that blockade
of IL-17 provides a high degree of
control of psoriasis,” Dr. Papp says.
“That IL-17 is instrumental in the
pathogenesis of psoriasis is proven.
The breadth of the response is a
demonstration of future hope of a
very effective treatment for psoriasis
and that IL-17 plays a pivotal role.”
Targeting the IL-17RA receptor, he
says, leads to a “profound response.”
While TNF antagonists have been effective, the progress in targeting IL-RA
represents “a quantum leap.”
Developing new treatments such as
brodalumab is particularly important in
the treatment of psoriasis, Dr. Papp says.
“Psoriasis patients need new therapies,”
he says. “We have really not been able to
fully address treatment of patients with
psoriasis and psoriatic arthritis. We
need new therapies and refinements of
those already in the clinic.”
Novel therapies can address problems commonly seen in the management of psoriasis, such as loss of
response and breakthrough symptoms.
The ixekizumab trial “showed that
the three largest doses (yielded) a high
performance with regards to clearing
psoriasis,” says
Dr. Leonardi
D r. L e on a rd i ,
who was also a
co-investigator in
the brodalumab
trial. “The two
studies together
validate the
i mpor ta nce of
blocking IL-17.
Both studies had very impressive
efficacy and (both drugs) were welltolerated.
Improvement is considered significant at the benchmark of PASI improvement of at least 75 (PASI 75). “For the
three highest doses of ixekizumab,
roughly 80 percent achieved PASI 75,”
Dr. Leonardi says. “In addition, 40
percent of patients treated with the two
highest doses achieved PASI 100,” or
complete clearing.
No adverse events
Tolerability results caused the investigators to characterize the trial as an
“absolutely quiet trial,” Dr. Leonardi
says. “There were no serious adverse
events of any type, not even accidental
injury,” he says. Instead, investigators
saw more common adverse events,
such as headache and pharyngitis,
but “none seemed dose-related.” Two
cases of neutropenia were seen.
In t he ongoing phase 3 tria l,
researchers will seek to determine
whether ixekizumab is associated with
any safety concerns in a larger database of participants. A phase 3 trial of
brodalumab is expected to launch later
in 2012. DT
Disclosures: Drs. Leonardi and Papp have
received consulting fees from both companies as well as others. Neither owns stock
in either company.
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Dermatology Times
clinical dermatology
Veinadvice
30
32
34
|
May 2012
New drug delivery
Laser device advancements
may target more than fat removal
Beyond aesthetics
Botulinum toxin plays role
for dermatologic conditions
Combination care
Pairing topical therapies
advantageous for psoriasis
Careful laser selection, combination therapies
set standard for vascular treatment
By John Jesitus
Senior Staff Correspondent
Vascular treatments are
undergoing a renaissance
that includes combinations
of lasers and sclerosing
technologies.
New York — The revolution in treatments
for venous incompetence includes combinations of lasers and sclerosing technologies
for leg veins, along with the gold standard
of pulsed dye lasers for facial telangiectasias, hemangiomas and port wine stains,
according to Neil Sadick, M.D.
Successful treatment requires choosing
the right wavelength to target blood vessels
lying at different levels within the dermis,
or those with thicker or thinner endothelial
linings, says Dr. Sadick, clinical professor
of dermatology at Weill
Dr. Sadick
Cornell Medical College,
New York.
“For facial telangiectasias, several wavelengths
can be utilized. For very
discrete blood vessels,
one can use a very short
wavelength 532 nm KTP
laser. The gold standard for
smaller vessels is the pulsed dye laser, at 585
to 600 nm,” along with intense pulsed light
(IPL) with cutoff filters at 500 nm to 1,000
nm, he says.
For larger blue vessels, particularly
around the eyes or in the temporal area, “We
sometimes use intermediate- or long-pulsed
1,064 nm Nd:YAG lasers,” Dr. Sadick says.
In treating rosacea, vascular-targeting
lasers can reduce not only hemoglobin and
flushing, but also inflammation, sebaceous
gland activity and the presence of pathogens
such as Demodex organisms around the
pilosebaceous units, Dr. Sadick explains,
adding that IPL devices are especially good
for diffuse flushing syndromes.
“For deeper f lushing syndromes,
we like using the intermediate-pulsed
1,064 nm Nd:YAG laser, particularly for
diffuse flushing syndromes, for deeper
and larger blood vessels and for darker skin
phenotypes and periorbital veins,” he says.
In treating hemangiomas, Dr. Sadick
says, “The pulsed dye laser is the gold
standard for superficial lesions. But for
deeper lesions, we sometimes use other
wavelengths.” For example, he says that
for thicker, deeper lesions, “We might use
a 1,064 nm Nd:YAG laser, or a 755 nm alexandrite laser. For more superficial vessels,
we may also occasionally use a very shortwavelength 532 nm KTP laser.”
For port wine stains, “We sometimes use
combination approaches as well,” he says.
“We usually treat the superficial vessels first,
then the deeper, more recalcitrant vessels.
Multiple treatments may be necessary. But
again, the pulsed dye laser is the gold standard. And we now treat these lesions earlier
in life because this approach is associated
with fewer treatments and better outcomes.”
Vascular advances see page 29
DT Extra
Few genes altered in XLRI patients
“Topical therapies are
important for virtually
everyone who has psoriasis.”
David M. Pariser, M.D.
Norfolk, Va.
t
a
On combination treatments for psoriasis
See story, page 34
e
g
e
t
A small number of genes have altered expression in
patients with X-linked recessive ichthyosis (XLRI), according to a study published online April 5 in the British
Journal of Dermatology. Researchers with Uppsala
University, Sweden, examined biophysical and molecular changes in the skin of 14 patients with XLRI and
14 controls. Patients with XLRI had increased dryness
and
a transepidermal water loss but equal skin pH. Patients
treated
tr e with moisturizers demonstrated improved skin dryness,
but
bu no
n effect on pH, transepidermal water loss or expression
of genes
n was found.
Source: HealthDay News
Getty Images/Collection/Credit
Quotable
May 2012
|
VascuLar adVancEs:
Treatments for venous incompetence grow from page 26
For leg veins, Dr. Sadick says he typically uses external lasers including the
gold standard long-pulsed 1,064 nm
Nd:YAG to target spider veins.
A 52-year-old
female patient
with volume
loss and visible
veins on the
hands before
(left) and eight
weeks after one
endovenous
laser treatment
for the hands.
Laser advances
In recent years, laser technologies have
improved through the inclusion of
advanced cooling technologies and the
ability to match the fluence, spot size
and pulse duration with vessel size and
color, Dr. Sadick says.
“Leg veins differ from facial telangiectasias because leg veins have increased
hydrostatic pressure. Also, lower
extremity vessels are larger and have an
increased thickness of the basal lamina
compared to facial telangiectasias,” he
says.
Dr. Sadick also says it’s more difficult
for light sources to access the deeper
location of lower-extremity veins.
Compared to facial telangiectasias,
he adds, leg veins also exhibit altered
cytokine patterns upon injury with light
sources. Therefore, “Different treatment
wavelengths and protocols are used in
treating leg veins versus facial veins.”
For example, he says that for superficial telangiectasias on the leg, which
have a reddish hue because they contain
increased amounts of oxygenated
hemoglobin, “We would use a 1,064 nm
Nd:YAG laser, but with a high fluence,
a short pulse duration and a small spot
size.”
Vessels that look more bluish usually
lie deeper, Dr. Sadick says. In such cases,
“We’d use the 1,064 nm Nd:YAG laser
with a slightly larger spot size and a
slightly more extended pulse duration.”
A larger spot size and longer pulse allow
the energy to be delivered to deeper,
slightly larger vessels, he explains.
Moreover, he says that after leg vein
treatment with light sources, patients
do not need compression therapy. In
a study that Dr. Sadick co-authored,
investigators used a tunable pulsed
dye laser (VBeam, Candela) to treat
both legs of 13 patients with leg veins
measuring 0.5 nm to 1.0 mm in diameter. They then had patients wear Class
II compression stockings on the left leg
during waking hours for one week.
At this point, investigators found no
significant differences between patients’
right and left legs in terms of results or
(Photos: Neil Sadick, M.D.)
side effects (Sadick NS, Sorhaindo L.
Phlebology. 2006. 21(4):191-194). Indications for cosmetic laser treatment of leg
veins (versus sclerotherapy) include the
presence of non-cannulizable vessels,
needle phobia, sclerosant resistance
and multiple sclerosant allergies, Dr.
Sadick says.
In recent years, dermatologists also
have revolutionized the treatment of
incompetence in axial veins including
the short and long saphenous vein by
using endovenous laser fibers operating
at various wavelengths to target either
hemoglobin, or water and collagen, Dr.
Sadick says.
Presently, dermatologists commonly
use diode lasers operating at 810 nm,
940 nm and 980 nm for this purpose,
he explains. “However, these lasers are
being replaced by longer-wavelength
water- and collagen-absorbing lasers
operating at 1,319, 1,320 and 1,470 nm.
Lasers that target water and collagen
rather than hemoglobin seem to be
associated with less patient discomfort
and post-treatment bruising.”
EVLT
Endovenous laser therapy (EVLT) of the
saphenous vein causes ablation of reflux
via vein occlusion, says Dr. Sadick. “It
also shrinks the vein by causing damage
to endothelial cells and the inner vein
wall, and secondary occlusion of the
lumen through the formation of a
blood clot.”
Additional advantages of EVLT
include the fact that it’s done as an
outpatient procedure under tumescent
anesthesia, the latter of which makes the
procedure virtually painless and bloodless, Dr. Sadick says.
After treatment, “Patients are
wrapped in an elastic bandage, then
undergo compression therapy for 10 to
14 days. But usually, they can go back
to work the next day,” he says, adding
that postoperatively, EVLT results in
very little discomfort, no scarring and
minimal downtime.
In practice, “We commonly use a
combination of EVLT with either foam
sclerotherapy of associated tributaries,
or ambulatory phlebectomy,” Dr. Sadick
says. With either approach, “It’s been
shown in long-term studies that the
outcomes in terms of recurrence are at
least as good as or better than those of
the older, more invasive surgical ligation
and stripping techniques.”
In one such study, Dr. Sadick and his
co-authors analyzed four-year followup data from a series of 90 patients
treated for greater saphenofemoral junction incompetence using 810 nm diode
EVLT plus ambulatory phlebectomy
of remaining truncal varicosities. To
ensure closure, investigators performed
duplex ultrasound examinations at one
week, then at one, three, six, 12, 24, 36
and 48 months post-treatment.
Among a total of 94 limbs treated,
researchers observed a recurrence rate
of only 4.3 percent (Sadick NS, Wasser S.
J Cosmet Laser Ther. 2007;9(1):9-13). DT
Disclosures: Dr. Sadick has received
research grants from Cutera, Cynosure,
Palomar, Solta and Syneron. He is also a
consultant for Solta and Cynosure.
29
30
Dermatology Times
|
May 2012
Noninvasive news
Future laser and other technologies
will target more than fat, physicians say
By John Jesitus
Wailea, Hawaii — In coming years, the
trend toward less invasive technologies
will continue not only in fat removal
and body sculpting treatments, but
also in new modalities for delivering
a variety of drugs, according to physicians who spoke at MauiDerm 2012:
Advances in Cosmetic and Medical
Dermatology in February.
“Some of the most exciting future
technologies include using fractional
laser technology to deliver drugs across
the skin,” says Omar Ibrahimi, M.D.,
assistant professor of dermatology,
dermatologic and Mohs surgery and
director of cutaneous laser and cosmetic
surgery at the University of Connecticut
Health Center, Farmington.
Recent research from the Wellman
Center has shown that “a single hole
made by ablative fractional resurfacing
(AFR) increases the delivery of a drug
logarithmically — it’s not just a two- or
fourfold increase. It’s manyfold,” he says.
“Some of the most exciting
future technologies include
using fractional laser
technology to deliver
drugs across the skin.”
Omar Ibrahimi, M.D.
University of Connecticut Health Center
In a porcine model, investigators
found that CO2 laser-ablated channels cut 1,850 µm deep, facilitating
significantly increased topical methyl
aminolevulinate (MAL)-induced
porphyrin fluorescence and photodynamic therapy (PDT) response, both
superficially and deep, versus topical
MAL alone (Haedersdal M, Katsnelson
J, Sakamoto FH, et al. Lasers Surg Med.
2011;43(8):804-813).
In an earlier porcine study, the same
Dermatologists increasingly
will use noninvasive devices
for much more than fat
treatments.
team of investigators found that treatment with an ablative fractional CO2
laser followed by topical MAL enhanced
drug delivery, providing significantly
higher porphyrin f luorescence of
hair follicles (P<0.0011) and dermis
(P<0.0433) versus MAL alone at skin
depths ranging from 120 µm to 1,800
µm (Haedersdal M, Sakamoto FH,
Farinelli WA, et al. Lasers Surg Med.
2010;42(2):113-122).
Other medical advances
“People are using fractional CO2 lasers
followed by PDT to enhance therapies
for skin cancers and actinic keratosis,”
says Michael H. Gold, M.D., medical
director, Gold Skin Care Center and
Tennessee Clinical Research Center,
and clinical assistant professor, Division
of Dermatology, Vanderbilt University
School of Medicine and Vanderbilt
University School of Nursing, Nashville.
“Those technologies are starting to play
a big role now.”
In a small case series, investigators
have shown how AFR with a fractional
CO2 laser improves MAL uptake and
may intensify results of treatments for
basal cell carcinoma (Haedersdal M,
Togsverd-Bo K, Paasch U. Lasers Med
Sci. 2012 Jan 6. [Epub ahead of print]).
Likewise, Dr. Gold says that with the
Legato iPixel plus ultrasound device
(Alma), commercially available in
Europe and Asia, “You can create holes
in the skin. Then you apply an active
onto the skin and ‘hammer’ it with
ultrasound into the skin. The plan is to
conduct U.S. trials on this device, which
are expected to start within the next six
to 12 months,” he says. “The machine
is doing very well outside the United
States, and its results are pretty impressive.” Dr. Gold says he has submitted
an article on the device for publication.
One very recent study shows that
investigators were able to vaccinate mice
using AFR (Chen X, Shah D, Kositratna
G, et al. J Control Release. 2012 Jan 9.
[Epub ahead of print]). Dr. Ibrahimi
says this study showed that it’s possible
to deliver large molecules through
the skin, “whereas traditionally you
couldn’t do that by topically applying
large protein or peptide molecules.”
Also in a mouse model, researchers
used a blue methylene dye and red light
to cure cutaneous Candida albicans
infections (Dai T, Bil de Arce VJ, Tegos
GP, Hamblin MR. Antimicrob Agents
Chemother. 2011;55(12):5710-5717. Epub
2011 Sep 19).
“AFR might ultimately be an ideal
way to deliver insulin to diabetics so
they won’t have to undergo needle
sticks. This technology has many promising applications,” Dr. Ibrahimi says.
regarding lipids
With energy-based treatments such as
lasers, Dr. Ibrahimi says, “Traditionally,
we’ve been targeting pigment, blood or
water in the skin. Now the next generation of applications might focus on
other targets in the skin, such as lipids,
which are present in sebaceous glands.”
In this regard, he says, research might
one day produce a laser that’s more
selective in treating acne than current
products are.
Unlike PDT, which requires a photosensitizing agent, “This would be using
a wavelength that’s absorbed more
selectively by sebaceous glands,” Dr.
Ibrahimi says. “There’s no photosensitizer needed.” Examples of such technology include the 1,720 nm laser under
development at Harvard’s Wellman
Center for Photomedicine, where Dr.
Ibrahimi is a visiting assistant professor
of dermatology.
May 2012
|
Presently, lipid- and acne-targeting devices are in
very early developmental stages, Dr. Ibrahimi says,
adding that such products likely will reach
the market within the next five years, Dr. Gold
dramatically changing the way acne is
treated.
aesthetic factors
“Around the world,” says Dr. Gold,
“researchers are looking at delivering
skin lightening agents, minoxidil and
botulinum toxins” using AFR. However,
he says that because it’s difficult to get a
prescription drug/device combination approved in
the States, “We’ll be looking at over-the-counter active
agents.” Examples could include hyaluronic acid for
skin rejuvenation, and skin-lightening ingredients such
as vitamin C and other skin-lightening actives, he says.
Fractional technology also might allow delivery of
growth factors or other wound-healing agents with
greater efficiency than is currently possible topically,
Dr. Ibrahimi says. He says that he and Suzanne Kilmer,
M.D., have used AFR to treat a handful of patients with
birthmarks, large congenital nevi or moles.
“We’ve found that it’s an effective way to lighten
these things and soften their appearance,” Dr. Ibrahimi
says. “I can envision these applications becoming more
popular in the future as well. We’re getting to applications beyond rejuvenation” with fractional lasers.
Focusing on fat
Dr. Gold says that presently, manufacturers and
researchers are focusing primarily on improving
existing devices that use cold or other targeted energy
sources to reduce fat or cellulite, possibly by adding
ultrasound or combining ultrasound and radiofrequency energy.
“The fat devices we have on the market now are the
CoolSculpting procedure (Zeltiq), Liposonix (Medicis),
and perhaps someday the Contour 1 (UltraShape),” he
says. “We’re taking these devices and seeing what kinds
of improvements can be made as we move into their
next generations.” He says that with ultrasound devices
particularly, “We’re looking for ways to decrease pain,
which will be very important.”
Dr. Ibrahimi says that future lipid-targeting wavelengths might facilitate noninvasive fat treatments that
appeal to patients hesitant to undergo more invasive
procedures. Fat-fighting lasers also might provide a
complement to the CoolSculpting procedure, which
essentially freezes off fat, but only in areas of skin that
can be drawn into its handpiece, he says. DT
Disclosures: Dr. Ibrahimi has received an honorarium
from Lumenis for a hair-removal study and owns stock in
Zeltiq and Procter & Gamble. Dr. Gold has received grant/
research support from Ulthera. He is also a consultant
for Syneron, Lumenis, Alma Lasers, Sciton, Ulthera and
Venus Concept, and a speaker for Alma Lasers, Lumenis
(in which he also owns stock), Syneron, Sciton, Ulthera,
Venus Concept and Jeisys.
Dermatology Times
|
May 2012
Expanding role
Clinical uses for botulinum toxin shine where standard therapies fail
By Ilya Petrou, M.D.
Lisbon, Portugal — Above and
beyond its therapeutic value in cosmetic
medicine, botulinum toxin can be
useful in a number of medical indications and can represent an adjunct treatment option, said Philippe Humbert,
M.D., Ph.D., at the 20th annual European Academy of Dermatology and
Venereology Congress last October.
Both physicians and the public are
well aware of the cosmetic benefits
that botulinum toxin can have in skin
rejuvenation treatments. The toxin can
also prove useful in the treatment and/
or relief of numerous medical conditions, including hyperhidrosis, inverse
psoriasis, hidradenitis suppurativa,
eccrine tumors and vestibulodynia, says
Dr. Humbert, professor and head of the
department of dermatology, University
Hospital, Besançon, France.
“The common denominator of many
dermatologic conditions and diseases
is increased sweating, which in many
cases can significantly aggravate the
affected skin region, particularly in the
folds of the skin. Treatments with botulinum toxin can at least temporarily
minimize the sweating, subsequently
resulting in an improvement of the
local symptoms, which often can offer
a great relief in affected patients,” Dr.
Humbert says.
sweating success
According to Dr. Humbert, botulinum
toxin treatments are very useful in
treating dermatologic conditions associated with profuse sweating in the skin
folds (axillary, inguinal and palmar
and plantar hyperhidrosis). Other
conditions associated with increased
sweating in the folds with subsequent
Botulinum toxin can
improve numerous
dermatologic conditions,
and physicians should
consider its use when more
conventional therapies fall
short.
skin maceration and localized pain
include inverse psoriasis, Hailey-Hailey
disease (benign familial pemphigus)
and Darier’s disease.
Many of these conditions are challenging to treat, manage and control,
Dr. Humbert says, and disease flare is
sometimes aggravated by increased
localized sweating (particularly in
the fold areas). “I believe that for these
dermatoses, botulinum toxin treatments should not be used as a monotherapy but instead used in combination
with more conventional therapeutic
approaches. Alleviating and/or stopping the localized increased sweating
can offer a better milieu for the affected
skin regions to heal,” Dr. Humbert says.
Botulinum toxin treatments could
be performed approximately every six
months, which is very similar to the
treatment protocols seen in cosmetic
medicine. The doses of botulinum
toxin used vary, Dr. Humbert says,
depending on the type of toxin used and
the severity of disease.
“It must be said that these indications
are off-label and do not offer a cure for
the patient,” he says. “As such, the physician has the difficult task to establish
that improvements achieved are due to
the botulinum toxin treatment. There-
fore, as these are symmetrical diseases,
I would suggest to treat one side of the
patient first and observe the therapeutic
benefit, and if there is a good response,
one can proceed to treat the other side.
This approach helps to establish the
treatment efficacy of the toxin in that
particular disease and patient.”
neurologic know-how
Botulinum toxin treatment can also
find utility in conditions and diseases
that have a neurologic component, such
as anal fissures, vestibulodynia, lichen
simplex and notalgia paresthetica, Dr.
Humbert says.
Traditionally, anal fissures were
surgically treated, he says, but the
toxin approach antiquates the need for
surgery. A one-time injection of 20 units
of botulinum toxin will often suffice to
close the fissure within only a few weeks
to a few months time.
Vestibulodynia can be a ver y
debilitating condition characterized by
chronic pain of the vulvar region, and it
occurs without any identifiable cause or
visible pathology. Patients will complain
of severe pain every time they have
contact with the vulvar area, and here,
botulinum toxin can help to alleviate
symptoms, Dr. Humbert says.
Dr. Humbert has treated more than
30 patients with botulinum toxin for
this condition, and he has achieved good
outcomes regarding pain relief. At the
three- and six-month follow-up after a
100 unit botulinum toxin treatment, he
says he found that the pain was significantly reduced in his patients. DT
Disclosures: Dr. Humbert reports no
relevant financial interests.
Getty Images/Science Photo Library/LAGUNA DESIGN
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Dermatology Times
|
May 2012
Perfect fit
Topical combination therapies for psoriasis
offer high degree of efficacy, safety
By John Jesitus
Norfolk, Va. — Topical combina-
tion treatments for psoriasis offer
a high degree of clinical efficacy,
patient safety and f lexibility in
designing treatment regimens, says
David M. Pariser, M.D.
“Combination therapy in psoriasis is absolutely the standard of
care,” says Dr. Pariser, professor
of dermatology, Eastern Virginia
Medica l School, and a Norfolk,
“Both the
American Academy
of Dermatology and
the National Psoriasis
Foundation include
combination therapy
in their guidelines
for psoriasis
treatment.”
David Pariser, M.D.
Eastern Virginia Medical School
Studies show that
combination therapies for
treating psoriasis provide a
wide variety of advantages.
Va., dermatologist in private practice. “Virtually all patients with
psoriasis are treated with combination therapy. If they’re on systemic
agents, there will often be a few
spots that don’t respond as well.
Therefore, topical therapies are
important for virtually everyone
who has psoriasis,” no matter how
mild or serious their disease.
“ To pi c a l c or t i c o s t e r oi d s i n
one form or another, usually the
more potent ones, are the most
commonly prescribed topical agent
for psoriasis,” he says. In addition,
“There’s a lot of interesting data on
combination therapy using vitamin
D topica l ly, a long w it h topica l
steroids.”
Meta-analysis
A recent meta-analysis of 50 randomized, controlled trials analyzed
combination psoriasis treatments in
comparison to monotherapies. When
researchers stratified results by corticosteroid class, Dr. Pariser says, “They
concluded that by adding a corticosteroid to a calcipotriene regimen,
the likelihood of disease clearance
increased by 28 percent for a Class 1
corticosteroid (95 percent confidence
interval/CI: 16 to 41 percent) and 14
percent for a Class 2 steroid (95 percent
CI: 5 to 22 percent; Bailey EE, Ference
EH, Alikhan A, et al. Arch Dermatol.
2011 Dec 19. [Epub ahead of print]).”
Compared to vitamin D derivative
monotherapy, combining vitamin
D with corticosteroids conferred a
22 percent higher likelihood of clearance, he says.
“That’s a significant finding that
supports the notion that we’ve all
had clinically over many years that
adding the corticosteroid to the
vitamin D does make it work better,
and over time can actually achieve
clearance” in the percentages specified above, Dr. Pariser says.
In two studies that contained
sufficient data to analyze efficacy
in terms of reductions in disease
severity scores, investigators found
that combination therapy with any
Perfect fit see page 36
Getty Images/Photodisc/Studio 504/Photographer’s Choice RF/Gregor Schuster
34
36
Dermatology Times
|
May 2012
PErFEcT FiT:
Combo therapies for psoriasis of fer ef ficacy, safet y from page 34
corticosteroid class decreased disease
severity by 1.52 units of standard
deviation (95 percent CI: -2.56 to
-0.48) versus vitamin D derivative
monotherapy.
Conversely, in the same meta-analysis, if patients used a Class 3 or weaker
steroid in combination with topical
vitamin D, it did not improve disease
clearance compared with vitamin D
derivative monotherapy, says Mark
Lebwohl, M.D.
Topical vitamin D
preparations carry very
few side effects,
Dr. Pariser says.
Product update
Combination products available in the
United States include a fixed combination of betamethasone dipropionate
and calcipotriene, Dr. Pariser says. In
a four-week study, the combination
product worked better than either
of its ingredients used separately, or
its vehicle (Kaufmann R, Bibby AJ,
Bissonnette R, et al. Dermatology.
2002;205(4):389-393).
In this study, investigators randomized 1,603 patients to one of four
double-blinded treatments: oncedaily combination ointment, betamethasone dipropionate ointment,
calcipotriol (known as calcipotriene
in the United States) ointment, or the
ointment vehicle.
When treatment ended, mean
percentage improvements in Psoriasis
Area and Severity Index (PASI) scores
were 71.3 percent, 57.2 percent, 46.1
percent and 22.7 percent, respectively.
Additionally, investigators concluded
that the combination treatment was
well tolerated: 6 percent of patients
who used it experienced local adverse
reactions, versus 4.9 percent of
betamethasone dipropionate users,
11.4 percent of calcipotriol users and
13.6 percent of vehicle users.
Patients a lso can accomplish
combination regimens by purchasing
topical steroid and topical vitamin
D products separately, or having
the combination compounded a
compounding pharmacy, Dr. Pariser
says.
CI: 22 to 47 percent). Conversely,
investigators found that vitamin
D-UVB combination therapy did
not confer a statistically significantly
higher likelihood of clearance when
compared to UVB monotherapy: the
increased likelihood calculated among
five studies of this type was 11 percent
(95 percent CI: -2 to 24 percent).
Options for regimens
side effects
Combination topical regimens can
take various forms, says Dr. Pariser.
For exa mple, a pu lsed regimen
involves a brief period of intense
steroid use followed by a period of
vitamin D use. In contrast, sequential
regimens consist of steroid followed by
vitamin D, each for a predetermined,
nonoverlapping time period.
Alternating regimens can involve
using a topical steroid in the morning,
then topical vitamin D in the evening,
or vice versa. Other regimens involve
weekday/weekend alternation, Dr.
Pariser says.
“Those are both effective ways to
do it. You can get about 80 percent
of patients’ psoriasis to be mild or
better by using the a.m./p.m. regimen.
Patients can do perhaps not quite as
well, with 60 percent to 70 percent
achieving mild or better ratings, and
perhaps up to 80 percent, by using the
steroid on the weekends and vitamin
D during the week,” he says. “That’s
generally what most dermatologists
do in terms of combination therapy.
They’ll gravitate toward one of those
approaches, or sometimes they’ll be
able to use both of those regimens.”
Topical vitamin D preparations carry
very few side effects, Dr. Pariser says.
These include minor irritation and
the theoretical side effect of altered
calcium metabolism as a result of
covering too much of the skin’s surface
with vitamin D analogues. “But even
in the clinical trials, that has never
manifested itself,” he says.
Side effects of topical steroid
overuse include local skin atrophy,
striae, telangiectasias, and, with
extreme overuse, the possibility of
systemic absorption and adrenal
suppression. “However, with the quantities that we would normally use for
treatment of psoriasis, those are not
really an issue,” he says.
Accordingly, “Both the American
Academy of Dermatology and the
Nat iona l Psor iasis Fou ndat ion
include combination therapy in their
guidelines for psoriasis treatment,”
Dr. Pariser says. One of the first publications to highlight the synergistic
effects of combining topical steroids
and vitamin D appeared 16 years ago
(Lebwohl M, Siskin SB, Epinette W, et
al. J Am Acad Dermatol. 1996;35(2 Pt
1):268-269.), he adds. DT
Phototherapy
As for the impact of combining phototherapy and topical vitamin D, the
meta-analysis mentioned above found
that two studies had sufficient data to
draw conclusions regarding clearance
efficacy.
In this regard, the combination
of vitamin D derivative and UVB
therapy increased the likelihood of
clearance by 34 percent versus vitamin
D derivative monotherapy (95 percent
Disclosures: Dr. Pariser has performed
clinical trials for all makers of topical
vitamin D analogue products available
in the United States, and for the maker
of the steroid/calcipotriene combination
product (LEO Pharma). However, he is
not a speaker or consultant for any of
these companies.
May 2012
|
SPECIAL REPORT
40
42
44
Better together
39
skin
Ipilimumab, radiotherapy
target metastatic melanoma
cancEr
Keep it simple
Ingenol mebutate gel works
quickly, easily for AK patients
Closer look
Photoacoustic devices help
guide lesion biopsy decisions
Expanding options
Novel melanoma therapies portend a ‘golden age’ of cancer care
By Paula Moyer
Staff Correspondent
National report — Several newly
approved therapies have changed and
are continuing to change the treatment
of melanoma therapy so that it is no
longer the “black sheep” of cancer
therapy, according to Adil Daud, M.D.
“These treatments have made a
tremendous difference to the treatment
of melanoma,” says Dr. Daud of what he
calls “game-changing” therapies such
as vemurafenib (Zelboraf, Genentech)
and ipilimumab (Yervoy, Bristol-Myers
Squibb). Dr. Daud is co-director,
Melanoma Program, University of
California, San Francisco.
“In 2010, when I would see a patient
with melanoma, I would say the likelihood of response was 20 percent. That
meant most patients would progress
(even) on treatment,” he says.
Broadened options
Getty Images/Studio ZooCollection/Imagezoo/Scott Heiner/iStock Vectors
Two melanoma experts
concurred w it h Dr.
Daud’s assessment.
Newly approved drugs such as
vemurafenib and ipilimumab are
creating a “game-changing” era
for treatment of metastatic
melanoma, clinicians say.
“Both of these agents have changed
our options,” says Edward S. McClay,
M.D., a medical oncologist in private
practice in San Diego, and director,
Institute for Melanoma Research and
Education, California Cancer Associates for Research and Excellence.
The genetic mutation that many
melanoma patients have is a type of
rapidly accelerating fibrosarcoma
(RAF) involving serine/threonineprotein kinase B, known as
BRAF.
“Vemurafenib is designed
to interr upt t he BR AF
pathway,” Dr. McClay says.
DT Extra
DT High
ExtraSPF sunscreens effective
Sunscreens with sun protection factors of 70 or higher
provide adequate protection against photodamage
and skin cancer, even with irregular application,
according to a study published in the Journal of the
American Academy of Dermatology. Researchers
with Neutrogena measured actual SPF values of six
sunscreens, SPF 30 to 100. Sunscreens with SPF 70
and 100 resulted in actual SPF values of 19 and 27,
respectively. A linear relationship existed between application density and actual SPF, researchers found.
“For patients who have this mutation,
there is a 50 to 60 percent chance of a
response.”
“Clearly, those two drugs have
created a huge shift in the way we are
going to manage melanoma,” says
Arkadiusz Dudek, M.D., Ph.D. He
is associate professor of oncology,
University of Minnesota, Minneapolis, where he heads the solid tumor
oncology group of the Cancer Experimental Therapeutics Initiative at the
Masonic Cancer Center.
“Before they were approved, we
only had one chemotherapy with very
little ability to control this disease.
High-dose interleukin-2 is also very
limited. These two drugs are the
result of our understanding better the
biology of melanoma,” Dr. Dudek says.
This improved understanding has
led investigators to understand that
BRAF-mutation melanoma will eventually develop resistance to vemurafenib.
“We are already developing the
drugs to delay resistance to vemura fenib,” Dr. Dudek says. “ The
Drug development see page 46
Quotable
“Patients with metastatic
melanoma have a lot more hope
now than they had previously.”
Michael A. Postow, M.D.
New York
On combining ipilimumab with radiotherapy
See story, page 40
40
Dermatology Times
SPECIAL REPORT
|
May 2012
skin
cancEr
potent combo
Radiotherapy boosts efficacy of ipilimumab in metastatic melanoma
By Diane Angelucci
Staff Correspondent
New York — Although ipilimumab
(Yervoy, Bristol-Myers Squibb) has
been a tremendous advance for
patients with metastatic melanoma,
only a subset of patients benefits from
treatment.
As researchers continue to study
the effects of adjunctive therapies
with ipilimumab, however, a recent
report suggests radiotherapy may
increase its efficacy, according to
Michael A. Postow, M.D., medical
oncology fellow, Memorial SloanKettering Cancer Center, New York.
“It wasn’t until the
radiation was
delivered that her
tumors started to regress
and decrease in size.”
Michael A. Postow, M.D.
New York
reported case
Dr. Postow is part of a team led by
medical oncologist and immunologist Jedd D. Wolchok, M.D., Ph.D.,
that reported in the New England
Journal of Medicine a case of a woman
with metastatic melanoma (Postow
MA, Callahan MG, Barker CA, et al.
N Engl J Med. 2012;366(10):925-931).
The patient had been enrolled in a
Although ipilimumab has shown
promise in treating metastatic
melanoma, only a subset of
patients benefits. Radiotherapy
combined with the drug,
however, may be efficacious in
some patients.
clinical trial and treated with ipilimumab as part of her treatment, which
failed to halt the spread of the disease.
However, after she received palliative
radiotherapy for back pain resulting
from a paraspinal mass, her targeted
paraspinal mass as well as lesions
outside the irradiated area remarkably regressed.
“What made this case particularly
interesting to us is that this is the
first time that we have seen that there
was a clear, documented case where
someone really benefited with a
combination of radiotherapy when it
was administered with ipilimumab,”
Dr. Postow says.
Researchers hope this finding
will lead to further investigation
of possible mechanisms of synergy
between the two anticancer treatments and potentially increase the
number of patients benefiting from
ipilimumab.
The patient’s response after radiotherapy hinted that radiotherapy
may have boosted the efficacy of
ipilimumab.
“It’s a little bit different in our
patient because she had been getting
ipilimumab for quite a long time,
and it hadn’t been working as we had
been hoping, in that her tumors were
slowly increasing in size,” Dr. Postow
says.
“It wasn’t until the radiation was
delivered that her tumors started to
regress and decrease in size,” he says.
The medical literature reports
a rare occurrence known as the
abscopal effect, resulting in regression of tumors outside the irradiated
area when radiotherapy is targeted to
one tumor area, Dr. Postow says.
role of the dermatologist
Dr. Postow urges caution in interpreting these results.
“I think this case report generates
great enthusiasm for the concept and
the possibility of synergy between
these two treatment modalities,” Dr.
Postow says. “But before we move
forward too definitively with these
thoughts, I think that this needs to be
tested more rigorously in a prospective clinical trial.”
Dr. Postow says he believes these
findings are promising, however. “I
think what’s important for dermatologists to know about this is this
exciting possible combination and
ipilimumab in general have dramatically changed the treatment of metastatic melanoma,” he says. “Patients
with metastatic melanoma have a
May 2012
|
SPECIAL REPORT
lot more hope now than they had previously.”
Dermatologists are often the first
physicians patients encounter when
they are diagnosed with melanoma, so
they need to understand all of the new
treatment modalities and how to counsel
patients before referral for medical or
surgical oncology evaluation.
“ These patients a re of ten quite
reasonably anxious when faced with this
initial diagnosis that they are typically
discussing first with their dermatologist,” Dr. Postow says.
Researchers believe one component
of ipilimumab differs from other anticancer treatments. In a small group
of patients, their disease disappears
or remains stable for many years, Dr.
Postow says.
“It’s enticing to imagine that there’s
a concept of cure for a small group of
patients,” he explains. “This is what is
driving much of the enthusiasm for this
medication.”
Less than 50 percent of patients
benefit from the drug, however, and a
phase 3 trial reported a median survival
of 10 months for previously treated
patients with advanced melanoma (Hodi
FS, O’Day SJ, McDermott DF, et al. N
Engl J Med. 2010;363(8):711-723), he says.
“So certainly there’s room to go, for
sure,” he says. “But the key component of
that is, there is a small slice of this population of patients that get this medicine
that do quite well for many, many years,
some of whom have all of their tumors go
away,” he continues.
Dr. Postow cautions against placing
too much weight on one case.
“What I do think is that if there are
any patients that need ipilimumab and
have a need for palliative radiotherapy
independently, there is a possibility of
synergy when delivered together,” he
says.
“We don’t believe that there’s any
particular hazard in trying that combination for the appropriate patient,
although we await the results of more
rigorous prospective trials to be more
definitive in any kind of recommendation for practice,” Dr. Postow says.
In this regard, however, he says
dermatologists may play an important
role by obtaining tissue biopsies from
willing patients to help medical and
surgical oncologists understand
how the immune system is either
eradicating or not eradicating
tumors and which tumor features
may be responsible for resistance to
the immune system.
41
“Cooperation in that regard may
really help advance our understanding of this disease,” he says. DT
Disclosures: Dr. Postow reports no
relevant financial interests.
,QWKHÀUVWOLQHWUHDWPHQWRIH[WHUQDOJHQLWDODQGSHULDQDOZDUWV(*:«
Put patients in the clear.
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posttreatment1
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3UHYHQWLRQ&'&6H[XDOO\7UDQVPLWWHG'LVHDVHV7UHDWPHQW*XLGHOLQHV
—Listed as a patient-applied treatment option for EGW
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$WZHHNVSRVWWUHDWPHQWLQWKHWZRSKDVHVWXGLHV
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 patients
or patients under 18 years of age, or
pregnant women, or for the treatment
The FIRST
of external genital and perianal warts
%27$1,&$/'58*
approved for prescription
beyond 16 weeks or for multiple
use in the United States
treatment courses.
The most common adverse reactions are
local skin and application site reactions
LQFOXGLQJLQFLGHQFHHU\WKHPD
pruritus, burning, pain/discomfort,
erosion/ulceration, edema, induration,
and rash vesicular.
5HIHUHQFHV VEREGEN®2LQWPHQW>3UHVFULELQJ,QIRUPDWLRQ@0HOYLOOH1<3KDUPD'HUP
a division of Fougera Pharmaceuticals Inc. :RUNRZVNL.$%HUPDQ6&HQWHUVIRU'LVHDVH&RQWURO
DQG3UHYHQWLRQ6H[XDOO\WUDQVPLWWHGGLVHDVHVWUHDWPHQWJXLGHOLQHVMMWR Recomm Rep.
55'DWDRQÀOH3KDUPD'HUP
Please see adjacent page for Brief Summary of full Prescribing Information.
9(5(*(1LVDUHJLVWHUHGWUDGHPDUNRI0HGL*HQH$*'3ODQHJJ0DUWLQVULHG*HUPDQ\
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42
Dermatology Times
SPECIAL REPORT
|
May 2012
AK alternative
Ingenol mebutate gel provides easy-to-use treatment option
skin
cancEr
By Louise Gagnon
Staff Correspondent
New York — The approval of ingenol
mebutate gel presents an easy-to-use
option to treat actinic keratoses (AKs),
but the flexibility in dosing of a treatment
like imiquimod will ensure its place in
the armamentarium of AK treatments,
according to the professor and chairman
of the department of dermatology, Mount
Sinai School of Medicine, New York.
“There is a big need for a drug that
works quickly,” says Mark Lebwohl,
M.D., who has conducted studies on
ingenol mebutate gel (0.015 percent for
face and scalp; 0.05 percent for trunk
and extremities), which is known by the
brand name Picato (LEO Pharma). “All
of the drugs are either very irritating or
somewhat irritating, and they have to be
used for a longer period of time. Most
patients want to get treatment over with
quickly rather than slowly.”
Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com
®
Veregen
(sinecatechins)
Ointment, 15%
Rx Only
For Topical Dermatologic Use Only
Nursing Mothers
It is not known whether topically applied Veregen® is excreted in breast milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
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
INDICATIONS AND USAGE
Veregen® is a topical ointment indicated for the treatment of external genital
and perianal warts (Condylomata acuminata) in immunocompetent patients
18 years and older.
Limitations of Use: Safety and effectiveness of Veregen® have not been
established in immunosuppressed patients, in treatment of external genital and
perianal warts beyond 16-weeks, or for multiple treatment courses.
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® should not be used to treat urethral, intra-vaginal, cervical, rectal,
or intra-anal human papilloma viral disease.
Use of Veregen® on open wounds should be avoided.
Avoid exposure of Veregen® treated areas to sun/UV-light as Veregen® has not
been tested under these circumstances.
USE IN SPECIFIC POPULATIONS
Pregnancy
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.
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.
Apply about an 0.5 cm strand of ointment to each wart using the finger(s),
dabbing it on to ensure complete coverage and leaving a thin layer of the
ointment on the warts.
Veregen® is not for ophthalmic, oral, intra-vaginal, or intra-anal use.
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 for:
Manufactured by:
C.P.M. Contract Pharma GmbH & Co. KG
Frühlingstrasse 7
D-83620 Feldkirchen-Westerham
Germany
U.S. Patent Nos. 5795911 and 5968973
98NVE060312
While imiquimod remains a go-to
therapy for actinic keratosis, ingenol
mebutate gel serves as a substitute
that works quickly and is easy for
patients to use, a clinician says.
The therapy is derived from the
active ingredient in the sap of the plant
Euphorbia peplus, regarded as a traditional remedy for common skin lesions.
Many current therapies for AKs,
which are precursors to squamous cell
carcinoma, have to be used for long
periods of time and are either somewhat or very irritating, according to Dr.
Lebwohl.
topical comparisons
Ingenol mebutate gel 0.015 percent is
used once daily on the face and scalp
for three consecutive days, while the
0.05 percent concentration is used daily
on the trunk and extremities for two
consecutive days.
Imiquimod 3.75 percent therapy, by
contrast, requires a six-week dosing cycle
consisting of once-daily, two weeks on,
two weeks off, and another two weeks
of daily treatment, for AKs that present
on the face and scalp. The therapy is
indicated for application to surface areas
larger than 25 cm 2 , whereas ingenol
mebutate is not. The therapy needs to
stay on the face for eight hours.
Applied in a less accelerated dosing
schedule than imiquimod 3.75 percent,
imiquimod 5 percent cream is applied in
a number of regimens with the approved
regimen being two applications per week
for four months. Like ingenol mebutate,
it is indicated to be applied to a contiguous area less than 25 cm2.
A topical therapy such as imiquimod
offers patients flexibility of dosing, Dr.
Lebwohl says. With Zyclara (imiquimod,
May 2012
|
SPECIAL REPORT
Medicis) cream 3.75 percent now available in another delivery model, a pump
rather than packets, it will allow patients
the opportunity to increase the amount of
the therapy they apply to the skin, he says.
“You are not limited to the amount
that you use whereas you are with a
packet,” he says. “You can dispense more
(and cover a wider area).”
Dr. Lebwohl describes the results of
treatment with either ingenol mebutate
or imiquimod as “amazingly comparable” and adds that the therapies are
also comparable in terms of their ability
to reduce recurrence of AKs.
treatment outcomes
Mo s t re c e nt l y, D r. L e bwoh l a nd
co-investigators published data in March
in the New England Dr. Lebwohl
Journal of Medicine
f rom fou r mu lt icenter, randomized,
double-blind studies
where patients were
randomly assigned
to receive eit her
ingenol mebutate or
placebo (Lebwohl M,
Swanson N, Anderson LL, et al. N Engl
J Med. 2012;366(11):1010-1019). They
observed statistically significant differences in the rate of complete clearance
of AKs on the face and scalp between
ingenol mebutate and placebo, 42.2 vs.
3.7 percent, p<0.001, and on the trunk
and extremities, 34.1 vs. 4.7 percent,
p<0.001.
Both therapies can cause local skin
reactions such as erythema, scabbing,
crusting, flaking, scaling and dryness,
Dr. Lebwohl says. In addition, swelling
around the eyes can occur.
For isolated lesions, Dr. Lebwohl says
most AKs are treated with cryotherapy,
but a field therapy is typically employed
to treat multiple lesions that are present.
Although most AKs do not develop into
invasive squamous cell carcinomas,
the relative risk of developing SCCs
increases with the number of AK lesions.
The ability, therefore, of a therapy to
treat not only clinically visible lesions
but also subclinical disease is significant.
Both ingenol mebutate and imiquimod
can act as field treatments, Dr. Lebwohl
says.
“They both clear fields very effectively,” he says.
Cost and reimbursement of a therapy
ultimately determine what therapy is
used to treat AKs, he says. Older thera-
pies such as fluorouracil, also referred to
as 5-FU, or diclofenac are typically used
before newer therapies such as imiquimod
or ingenol mebutate.
“Insurance companies, to a large degree,
determine what we use (to treat AKs),” Dr.
Lebwohl says. “It (5-FU) is quite irritating,
and the treatment lasts for weeks. Compliance is a challenge because of skin irritation and how long the therapy needs to be
applied.”
In i mmu nocompromised pat ients,
imiquimod as a therapy to treat AKs has
been studied to be both safe and effective
while ingenol mebutate has not been tested
in populations of patients who have undergone organ transplants. DT
Disclosures: Dr. Lebwohl is a paid consultant for
LEO Pharma.
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44
Dermatology Times
SPECIAL REPORT
|
May 2012
skin
cancEr
id assistance
Photoacoustic devices help clinicians to determine
which lesions to biopsy
By Paula Moyer
Staff Correspondent
New York — Newly available photo-
acoustic devices can help dermatologists identify which pigmented
lesions to biopsy, according to Darrell
S. Rigel, M.D., M.S. Such devices
only aid the trained specialist in the
assessment of such lesions, however,
and do not substitute for the professional, he says.
“Nothing replaces a good set of
eyes,” says Dr. Rigel, clinical professor
of dermatology, New York University
Medical Center. “Typically, patients
come in with multiple lesions, and
you have to determine which to
biopsy. That’s where the devices
come in. They give you another piece
of information to help you with the
biopsy decision.”
“Typically patients come
in with multiple lesions,
and you have to determine
which to biopsy. That’s
where the devices come in.”
Darrell S. Rigel, M.D., M.S.
New York University Medical Center
The various digital programs
that have developed in the 21st
century use different mechanisms to
identify pigmented lesions that are
suspicious for melanoma. The most
recent to be approved, MelaFind
(MELA Sciences), obtains data about
atypical pigmented lesions about
atypical pigmented lesions from up to
2.5 mm below the cutaneous surface.
New photoacoustic screening
devices will facilitate clinicians’
decision-making regarding which
pigmented skin lesions to biopsy.
All involve some learning curve,
however, and none replace a
dermatologist’s trained eye.
It uses 10 wavelengths varying from
450 nm to 950 nm and can visualize
lesions as small as 20 µ in diameter.
The system then incorporates the
data into an algorithm that makes a
biopsy recommendation and displays
the suspicious lesion in the various
wavelengths.
Formulas and thresholds
“The new digital systems all work
differently,” Dr. Rigel says. “Some
enter the data into an algorithm automatically, while some require that the
operator enter the information. Some
require so much manual input that by
the time you enter the data, you know
whether or not to biopsy the lesion.”
Some require skilled technologists,
while others are virtually operatorindependent, he says. Some, such as
MelaFind, gather information with
light while others utilize ultrasound
or genetic analysis.
“The idea behind it is to determine
whether a biopsy is necessary, and
they all work on formulas,” Dr. Rigel
says.
The formula will score the lesion so
that lesions above a certain threshold
get a biopsy recommendation while
those below that threshold will be
considered benign and therefore not
needing a biopsy. Because the worst
scenario is to miss a melanoma, all of
the devices are adjusted to increase
the sensitivity of detecting a melanoma, he says.
S e ve r a l ne w d e v ic e s s hou ld
become available in the next few
years, Dr. Rigel says, noting that the
approval of Verisante Aura (Verisante Technology) is expected soon.
Verisante Aura takes advantage of
the principle that melanoma lesions
have a different vibrational frequency
than healthy tissue when visualized
by monochromatic light. The system
utilizes multiple biomarkers for
melanoma and other skin cancers to
identify lesions for biopsy.
A l l of t he de v ic e s i nvolve a
learning curve, Dr. Rigel says.
“You can’t teach in a short training
session which lesions to image,” he
says. “Dermatologists will still have
to have the primary judgment in
making the biopsy decision.”
in the pipeline
Other systems currently in the investigational pipeline will be of interest
to dermatologists as well. One system
utilizes mRNA information from
suspicious moles. The dermatologist
puts tape on the tested mole. When
the tape is removed, the mRNA on
the tape is analyzed. The results still
take several days to come back to the
dermatologist, however.
Another system utilizes a probe
placed on both sides of the mole and
takes advantage of the fact that melanoma cells differ in their electrical
resistance from healthy cells.
Biopsy decisions see page 46
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46
Dermatology Times
SPECIAL REPORT
|
May 2012
skin
cancEr
drug dEvElopmEnt:
New approvals augment cancer therapy options
potential for broadened treatment
options created a lot of interest in
new approaches to treating melanoma, such as combining drugs,
determining which drug to use first,
whether to use high-dose IL-2 first.”
cost may be barrier
Dr. Daud cautions that the new therapies come with encumbrances of cost
and adverse effects. The high cost of
the new treatments is particularly
worrisome, he says.
Vemurafenib costs approximately
“I’m very concerned that
drug companies are pushing
the boundaries with these
prices. We risk a regulatory
backlash.”
Adil Daud, M.D.
University of California, San Francisco
$9,400 per month, with a treatment typically lasting approximately six months,
or a total cost of $56,400. Ipilimumab
costs approximately $30,000 per infusion, so that a full course, consisting of
four infusions in a three-month period,
costs $120,000. The specter of significant treatment barriers is obvious and
serious, according to Dr. Daud.
“I’m very concerned that drug
companies are pushing the boundaries with these prices,” he says. “We
risk a regulatory backlash.”
from page 39
One potential affordability issue
that can arise is that some insurance
companies don’t consider vemurafenib a cancer therapy because it
is administered orally, and therefore
they categorize it as a prescription
drug, Dr. McClay says.
“For patients with a 20 percent
co-pay, that approach can make the
cost of care prohibitive,” he says,
but he notes that the manufacturer
often finds ways to help patients with
affordability issues.
adverse effects
Further, these drugs are associated
with adverse effects with which clinicians are struggling to familiarize
themselves. For example, Dr. Daud
says vemurafenib is associated with
squamous cell cancer and excessive
photosensitivity. Therefore, in his
practice, patients on vemurafenib see
a dermatologist monthly. Ipilimumab
is associated with autoimmune colitis
and hormone deficiency syndromes.
“Both these drugs have unusual
side effects with some learning
curves,” he says.
The adverse effects associated
with these therapies differ from the
typical chemotherapy-related effects,
clinicians using them need to know
how to manage them, Dr. Dudek says.
For example, the hypersensitivity
and photosensitivity associated with
vemurafenib necessitate collaboration
between oncologists and dermatologists. The autoimmune effects associated with ipilimumab, such as colitis
and rashes, should also be on the radar
of clinicians using this therapy.
However, these hurdles need to be
seen in the broader context of their
overall contributions to melanoma
treatment, Dr. Daud says.
“This is a golden age for melanoma
therapy,” he says.
the place for vismodegib?
Dr. Daud was less optimistic about
a role for vismodegib (Erivedge,
Genentech/Roche), recently approved
for the treatment of metastatic basal
cell carcinoma.
“This is a modest advance clinically because metastatic basal cell
carcinoma is very rare,” he says.
While metastatic basal cell carcinoma is relatively rare, Dr. McClay
says he saw a role for vismodegib
in patients who have large tumors
in difficult areas, such as the face,
where surgical removal could create
intolerable defects. Vismodegib can
also shrink such lesions to a resectable size, and may expand options for
patients with multiple recurrences.
“It provides us with an option not
there before,” he says. DT
Disclosures: Dr. Daud has received
research funding from Roche, GlaxoSmithKline and Pfizer. He has consulted for
and Bristol-Myers Squibb and Merck. He
reports no financial shares or other interests. Dr. McClay is a speaker for Genentech/Roche, but he owns no stock the
company. Dr. Dudek reports no relevant
financial interests.
Biopsy dEcisions:
Photoacoustic devices help to guide actions from page 44
a discerning look
should also learn from a variety of the meantime, Dr. Rigel says dermaWhen new devices become available,
Dr. Rigel urges dermatologists to be
discerning.
“We need to know how a device
is tested to validate it,” he says. “The
original data set where the device
learns from the lesions should be
from multiple centers and consist of at
least 1,000 pigmented lesions.”
The validating data set should also
be at least 1,000 pigmented lesions
and consist of different lesions from
the original set, he says. The system
lesions.
“If it is only exposed to advanced
melanomas, it would be easy to test,”
Dr. Rigel says.
At their best, the new devices will
help dermatologists to be more accurate.
When tested without such aids against
data sets of pigmented lesions, dermatologists correctly identify 80 percent of
melanomas, while primary care physicians’ accuracy rate is 20 percent, he says.
Eventually, some systems will
prove to be superior to the others. In
tologists need to know the quality of
science behind any digital screening
system they are considering for their
own practices. DT
Disclosures: Dr. Rigel has consulted
for MELA Sciences, developing digital
systems for screening pigmented skin
lesions. He reports no other relevant financial interests.
For more information: Rigel DS,
Russak J, Friedman R. CA Cancer J Clin.
2010;60(5):301-316.
May 2012
|
cosmetic dermatology
50
53
49
cosmetic conundrums
Skin assessment
Pigment measurement tool
boosts safety of laser device
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 email to
zdraelos@northstate.net.
Injecting synergy
Newer technologies address
facial aging in patients of color
DNA discoveries
Exploring theories, potential opportunities
of gene-matched cosmetics
Q
Is it possible to
design a cosmetic
to match a
patient’s genes?
Getty Images/Science Photo Library/PASIEKA
a:
One new marketing
concept is to design
boutique cosmetics that
complement the genes of the consumer.
This idea builds on the current genomic
approach to cosmeceutical research where
gene expression is being used to study the
effect of ingredients on the skin.
Problems arise when extrapolation is
made from one individual gene in one cell
turning on at a molecular level and the
appearance of the skin. The behavior of
many, many, many cells must be influenced
for the skin to undergo a change observable by the cosmetic user. It actually is
unknown how single genetic changes translate into appearance changes.
It is possible to design a cosmetic to
match a patient’s genes, but it’s uncertain
exactly what this means. Some companies
have the consumer fill out a questionnaire
regarding skin type, eye color, hair color,
tendency to sunburn, lifestyle habits,
ethnicity, degree of photodamage, etc. Much
of the information needed to recommend a
skin care regimen can be obtained from this
type of questionnaire because the ability to
fit specific ingredients to specific skin needs
really has not evolved to the genetic level.
DT Extra
A buccal mucosal swab may also be
submitted supposedly with the consumer’s
DNA, but how this is processed and analyzed
is subject to controversy. There have been
some Federal Trade Commission inquiries
into this process.
Sequencing the genome of an individual is expensive, and specific markers
for certain skin conditions are still beyond
the reach of current technology. Designing
cosmetics to meet specific genetic needs
may still be more marketing hype than
practical reality.
Q
How effective are
the new at-home
blue light devices
for treating acne?
a:
Several devices have
been introduced into
the at-home market for
treating acne. Some of the devices simply
use resistive heating to warm the acne
lesion. While corporate studies show a
reduction in acne lesion healing time by
two days, it is hard to do a controlled study
of acne lesions because they heal without
intervention.
These heating devices claim to speed
acne lesion healing, but they are not preventative. This is in contrast to the blue light
devices that do not claim to speed acne
lesion healing, but prevent the development
ICG laser clears leg veins
Telangiectatic leg veins treated with indocyanine green (ICG)-augmented diode
laser therapy achieve good clearance,
according to a study published in Lasers
in Surgery and Medicine. Researchers with
University Hospital Regensburg, Germany,
gave ICG intravenously in 15 female patients, and then applied diode laser pulses
with different radiant exposures. Diode
laser treatment at radiant exposures of 100
J/cm2 to 110 J/cm2 led to good clearance.
of new acne lesions. Blue light energizes
the porphyrins in Propionibacterium acnes
(P. acnes) organisms and kills the bacteria
that may be responsible for acne, however,
newer theories of acne etiology indicate that
the P. acnes may be a bystander and not an
initiator of acne. This may explain why blue
light does not cure acne.
It has been demonstrated that blue
light can improve acne, but the home
use devices have some challenges. The
devices are to be used with goggles
similar to those used in tanning
booths, which provide limited vision.
The device must be stroked over
the face for prevention and held
over the individual acne lesions for
treatment. It is estimated that this
procedure takes 30 minutes for each
side of the face, making total treatment
time around one hour. Of course, this
may vary depending on the number of acne
lesions, the size of the face, the severity of
acne, the size of the blue light aperature,
and fluence of the light device.
Most device studies have demonstrated results similar to topical benzoyl
peroxide. Home blue light devices are a
newcomer to the over-the-counter acne
treatment market, and further data accompanied by design improvements may be
forthcoming. DT
Quotable
“I tend to work with lower
doses of neuromodulators, in
conjunction with fillers.”
Hema Sundaram, M.d.
Washington
On combining treatments for patients of color
See story, page 53
50
Dermatology Times
|
May 2012
light on lasers
Joely Kaufman, M.D.,
is in private practice at
Dr. Brandt Dermatology
Associates and a
voluntary assistant
professor, University
of Miami Department
of Dermatology &
Cutaneous Surgery.
Jeremy Green, M.D.,
is in private practice at
Dr. Brandt Dermatology
Associates and a
voluntary assistant
professor, University
of Miami Department
of Dermatology &
Cutaneous Surgery.
Elizabeth R. Geddes,
M.D., a resident at the
University of Texas Health
Science Center, Houston
Medical School.
Melanin insights
Pigment measurement tool can increase safety,
efficacy of light-based devices
T
he primary goal of the dermatologic laser surgeon is to
deliver effective treatments
without compromising patient
safety. Laser and light-based technologies continue to evolve at a torrid pace,
whereas the methodology by which laser
surgeons assess the skin to be treated
has lagged behind.
Fitzpatrick’s eponymous skin-typing
scale was introduced in 1975 to aid
in determining therapeutic UVA light
doses for oral methoxsalen photochemotherapy in white patients typed
I to IV (Fitzpatrick TB. J Med Esthet.
1975;2:33034). Later expanded to
include darker skin types, his system
is a subjective assessment based on
genetic disposition (eye, hair and skin
color as well as freckling), tanning habits
and reaction to sun exposure that, when
combined with the laser surgeon’s therapeutic experience, dictate device treatment parameters (Fitzpatrick TB. Arch
Dermatol. 1988;124(6):869-871).
Melanin absorbs light over a broad
spectrum, most avidly in the ultraviolet
domain, and its absorbance decreases
through the near-infrared spectrum.
Patients with darker skin and higher
melanin density are at increased risk of
injury when they are treated with light
energy in the visible and near-infrared
spectrum. Thus, the pretreatment skin
type assessment is absolutely crucial to
ensure procedural safety.
There are some commercially available noninvasive devices that aim to
reduce the subjectivity of skin-type
assessment by quantifying the amount
of melanin in the skin. Due to their costs,
cumbersome design, and inability to reliably distinguish between erythema and
The primary
goal of the
dermatologic
laser surgeon
is to deliver
effective
treatments
without
compromising
patient safety.
melanin, however, these devices have
primarily been employed for research.
In previous investigations, such
devices have been used to objectively
measure skin color and determine the
efficacy of lightening agents on melasma
(Shin JW, Choi SY, Park KC. J Dermatol. Epub 2 Dec 2011) and lentigines
(Yoshimura K, Harii K, Aoyama T, et al.
Aesth Plast Surg. 2001;25(2):129-133).
They have also been found useful in
differentiating vitiligo from nevus depigmentosus (Park ES, Na JI, Kim SO, et
al. Skin Res Technol. 2006;12(4):298302), as well as in evaluating treatment
response of these conditions to narrow
band UVB therapy (Hwang SW, Kang
JH, Jung SO, et al. Ann Dermatol.
2010;22(4):482-485).
The majority of these products utilize
reflectance spectroscopy, which operates
on the premise that two main chromophores contribute to skin color — melanin
and hemoglobin. Light is delivered to the
target surface via a probe and a photodetector is used to collect the reflected light.
The more melanin in the skin, the less light
reflected. However, in order to account for
the contribution of hemoglobin, more than
one spectral band must be assessed (Stamatas GN, Zmudzka BZ, Kollias N, Beer
JZ. Pigment Cell Res. 2004; 17(6):618-626).
Current classes
The two main classes currently in use
are the tristimulus reflectance colorimeters, which include the Minolta Chroma
Meter and Photovolt ColorWalk, and the
narrowband reflectance spectrophotometers, examples of which are the Cortex
Technologies DermaSpectrophotometer
and the Courage+Khazaka Mexameter.
The tristimulus colorimeters emit white
light and use a photodiode or specific
wavelength filters to measure the intensity
of the reflected light, which is analogous
to the way the human eye detects color —
shades of red, green and blue. Results are
conveyed in a standardized color system,
L* (lightness/darkness), a* (green/red), b*
(yellow/blue), with L* and b* values most
often used to express pigment.
Narrowband spectrophotometers
utilize the fact that melanin and hemoglobin have different spectral curves for
light absorption. Hemoglobin has a large
peak in the green light wavelengths with
little absorption of red light wavelengths,
and melanin readily absorbs red light.
The reflectance of narrowband red light
can provide an estimate of the amount of
melanin in the skin (Taylor S, Westerhof
W, Im S, Lim J. J Am Acad Dermatol.
2006;54(5 Suppl 2):S282-S290).
Spectrophotometers use light emitting diodes (LED) of specific wavelengths
and express the computed results in melanin and erythema indices. One example
May 2012
|
is the Mexameter, which uses the intensity of
absorbed and reflected light at 660 nm (red)
and 568 nm (green) for erythema and 660
nm (red) and 880 nm (near-infrared) for melanin (Clarys P, Alewaeters K, Lambrecht R,
Barel AO. Skin Res Technol. 2000;6(4):230238). Readings of 0 and 999 correspond to
white and black, respectively.
A few clinical studies have compared
these two types of devices. Shriver and
Parra found a strong correlation between
the melanin index (MI) and L* value and
concluded that both devices provide accurate measurements of skin and hair color
in persons of European, Asian and AfricanAmerican ancestry (Shriver MD, Parra EJ.
Am J Phys Anthropo. 2000;112(1):17-27).
In a comparison of the tristimulus
chromameter and the narrowband spectrophotometers the Mexameter and the
DermaSpectrophotometer for evaluation of
various skin color changes (erythema, irritation, blanching, artificial and UV tanning), it was
found that the sensitivity and reproducibility of
all devices were good. The Mexameter showed
the weakest sensitivity, but the day-to-day
repeatability of melanin measurements was
better for the narrow band spectrophotometers
(Clarys P, Alewaeters K, Lambrecht R, Barel
AO. Skin Res Technol. 2000;6(4):230-238).
One of the more challenging considerations when measuring changes in pigment is how to minimize the confounding
effects of erythema that can occur with both
bleaching regimens and phototherapy.
The narrowband spectrophotometers
may be more appropriate in this situation
(Yoshimura K, Harii K, Aoyama T, et al. Aesth
Plast Surg. 2001;25(2):129-133) and have
shown to be less affected by increased
redness of certain body sites secondary to
higher vascularization (Shriver MD, Parra
EJ. Am J Phys Anthropo. 2000;112(1):17-27).
Efforts should be made to keep environmental conditions constant in position and
temperature and the probe held correctly
to avoid pressure and blanching (Taylor S,
Westerhof W, Im S, Lim J. J Am Acad Dermatol. 2006;54(5 Suppl 2):S282-S290).
New to the market
The latest entry into this device class is the
Skintel Melanin Reader (Palomar Medical
Technologies). The Skintel is a narrow-band
spectrophotometer consisting of LED lights
of three wavelengths (640 nm, 700 nm, 910
nm). The device measures skin reflectance
based on epidermal thickness, wavelength
and average absorption coefficient to obtain
a value called the melanin optical density
light on lasers see page 52
51
One of the more challenging
considerations when measuring
changes in pigment is how to
minimize the confounding
effects of erythema that can occur.
For the symptoms of
psoriasis and severe eczema
6JGUVTGPIVJ
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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
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t Offers flexible QD–TID dosing options
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t Available for eligible patients
Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations
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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).
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
52
Dermatology Times
Based on our experience, the ability to
quantify cutaneous melanin levels
eliminates the subjectivity inherent in the
current means of skin assessment.
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
|
May 2012
Light on Lasers
f rom page 51
(MOD). The higher the MOD, the lower the
damage threshold of the epidermis.
The calculated MOD minimizes the effect
of tissue scatter and the competing chromophore hemoglobin. The MI measured by
the Skintel device is directly proportional to
the MOD and is expressed in values ranging
from 0 (white) to 99 (black).
The Skintel is handheld and is applied to
clear facial skin, not directly over hair, lentigines or other pigment that could influence the
reading. Each measurement is taken in less
than a second, and after three measurements
the device wirelessly transmits the average MI
to the intense pulsed light (IPL) base station.
The user can then utilize this information to
help in selecting the optimal treatment setting.
The authors’ practice consists of a
diverse patient population, including many
patients of Latin American and Caribbean
descent. Unlike other devices we’ve tried, we
found the Skintel quantification of melanin
to be very consistent and usually within one
to two units when measured on the same
person in the same region several times.
We also compared our pulsed light settings that were developed based upon years
of experience without the use of Skintel to
the recommended starting test spot fluence
settings using Skintel readings. Recommended fluence settings were at or just
below our experienced-based settings and
helped streamline the number of test spots
needed to identify optimal treatment settings. In some cases, particularly with mixed
ethnicities, the MI readings gave us an excellent starting point for settings and increased
our confidence in treating challenging
patients with our IPL device.
Due to its ease of use and reliability,
the authors have also used the Skintel
to assess patients’ MI prior to other
treatments, including fractional, qualityswitched pigment and tattoo lasers, as
well as longer-pulsed vascular and hair
removal lasers.
Based on our experience, the ability to
quantify cutaneous melanin levels eliminates the subjectivity inherent in the current means of skin assessment, thereby
providing an added level of patient safety
for both beginning and advanced laser
surgeons. DT
Disclosures: Drs. Green and Kaufman
have received research grants from
Palomar Medical Technologies.
May 2012
|
Colorful world
Newer injectables, energies prove to suit darker skin types
By John Jesitus
Washington — Just as they do in lighter- an ideal filler for that.” Belotero Balance also
skinned patients, new injectable and allows very precise definition of the lip borders
energy-based aesthetic treatments work and restoration of the white roll at the vermilion
synergistically for patients of color, border, she says. “You can inject it all along the
according to Hema Sundaram, M.D.
In particular, combining newer neuromodulators and fillers with the latest
radiofrequency (RF) and ultrasound-based
treatments can provide results that are greater
than the sum of their individual parts, says
Dr. Sundaram, a Washington dermatologist
and cosmetic surgeon in private practice.
“The idea is to look at each patient
individually. What
Dr. Sundaram
combination of procedures is going to give
the patient what he or
she is looking for —
or hopefully results
above and beyond what
they’re looking for?”
she says, adding that
this requires an understanding of the patterns of aging, which
are unique in skin of color, and how newer
technologies can help address these changes.
In the latter area, Dr. Sundaram says
combining newer injectables and technologies
allows multi-plane rejuvenation — targeting
tissue levels from the epidermis to the subcutaneous and supraperiosteal tissue and the
superficial muscular aponeurotic system
(SMAS). “By combining treatments that
address different tissue planes, we can get a
very good synergistic effect,” she explains.
Injecting synergy
Among injectable fillers, “Belotero Balance
(Merz/BioForm) is a different type of hyaluronic acid (HA) filler,” Dr. Sundaram says.
Because it’s a cohesive polydensified matrix
HA, “When you inject it, it distributes very
smoothly and homogeneously through the
skin, so there are no lumps or particles. That
means you can inject it very superficially.”
The product contains no particles to scatter
back shortwave blue light, she adds, so injectors
need not worry about the Tyndall effect. These
characteristics make Belotero Balance especially well suited to fine lines, Dr. Sundaram
says. “Although we as clinicians often think
in terms of volumizing the face, patients are
still very concerned about fine lines such as
smokers’ lines in the perioral region. This is
border, and superficially, and it will give a very
nice restoration.”
On a broader scale, she says this product fits
Colorful world see page 54
53
54
Dermatology Times
|
May 2012
Colorful World:
Injectables, energ y-based devices rejuvenate darker skin from page 53
well within the multiplane rejuvenation technique. Dr. Sundaram uses high-viscosity, high G
prime fillers such as Radiesse (calcium hydroxylapatite, Merz) or Perlane (HA, Medicis) for deep
lifting volumization. “The high G prime confers
a lot of lift; the high viscosity confers contour
stability. I inject above the bones in the supraperiosteal plane, or subcutaneously,” she says.
Dr. Sundaram then uses Belotero Balance
superficially to get what she calls superficial tension
volumization. “I run it through the dermis as a
sheet. For all patients, including patients of color,
injecting into the dermis creates a phenomenal
restoration of radiance to the skin. It’s a very
lustrous appearance, because you’re re-volumizing
superficially,” she says.
Additionally, physicians can use Belotero
Balance for fine lines that remain after treatment
with Botox (onabotulinumtoxinA, Allergan),
Dysport (abobotulinumtoxinA, Medicis) or
Xeomin (incobotulinumtoxin, Merz) in areas
such as the forehead. “You can’t completely freeze
the forehead or overinject neuromodulators there because that may look unnatural or drop the eyebrows,” she says.
Presently, “I tend to work with lower
doses of neuromodulators, in conjunction with fillers,” Dr. Sundaram says.
“For instance, for the forehead or
glabella, I might be using 20 to 22 units
of Xeomin or Botox. The equivalent for
Dysport would be about 50 to 55 units.”
Among new neuromodulators,
“Xeomin behaves exactly the same as
Botox terms of dosing, effects, onset
of effects and longevity. But it’s a purified toxin that doesn’t have accessory
proteins,” as Botox does, she says.
Xeomin’s lack of accessory proteins
is considered an advantage in some
respects, Dr. Sundaram says, because it
may decrease the risk of resistance.
“It makes for a very predictable
neuromodulator,” she says. “We now
have some evidence from basic science
literature that the accessory proteins
influence behavior of the toxin, even
though they are supposed to dissociate
from the toxin within a minute or two
after injection (Cheng LW, Onisko B,
Reader JR, et al. Toxicology. 2008;249(23):123-129. Epub 2008 May 2).”
Conversely, she says Dysport has a
broader field of effect, which physicians
can leverage to patients’ advantage. In
the lower face, for example, “Because
of the beneficial spread, I can target
a little bit of the depressor anguli oris
along with the platysma to accomplish
neck lifting and target a little bit of the
masseter to achieve lower-face slimming. You can target multiple treatment
areas from just a few injection points.”
A split-face controlled study on which
Dr. Sundaram served as a principal
investigator in collaboration with San
Diego dermatologist Mitchel Goldman,
M.D., has shown that for crows’ feet
in various skin types, Dysport via one
injection site performs comparably to
the same dose of Dysport delivered via
three injection sites (American Society
for Dermatologic Surgery Annual
Meeting. Nov. 3-6, 2011. Washington).
“You inject the same dose as you would
with three injection points, but using
one injection point may be beneficial
because it reduces the risk of bruising
and increases patient comfort,” she says.
Getting energized
As for energy-based treatments, Dr.
Sundaram says that the Ulthera device
May 2012
|
(Ulthera) delivers microfocused
ultrasound energy at 3 mm,
targeting the deep dermis, and
at 4.5 mm, targeting the hypodermis, the SMAS and in the
submental area, the platysma.
In a recent study, “We looked
at a very novel paradigm where
we added additional targeting
at 1.5 mm, which is superficial
within the dermis,” she says.
With this approach, patients had
no post-treatment downtime, as
the device spared the epidermis.
“That’s important for patients
of color — sparing the epidermis
resu lt s i n a no -dow nt i me
procedure and reduces or even
eliminates the risk of postinflammatory hyperpigmentation,”
she adds. “Nevertheless, using a
validated scale, we saw significant
improvement in pigmentation,
particularly for the under-eye
circles (Sundaram H, Onwudiwe
O. American Society for Dermatologic Surgery Annual Meeting.
Nov. 3-6, 2011. Washington).”
I n a n o t h e r s t u d y, D r.
Sundaram and her colleagues
addressed pain control. In this
double-blinded pilot study,
researchers compared the impact
of giving a single pretreatment
dose of hydrocodone plus acetaminophen versus ibuprofen 800
mg one hour before treatment.
“Then we did a full-face
Ulthera treatment, upper and
lower face, and asked patients
to use a validated 10-point pain
scale to assess their comfort level
after treatment of each region,”
she says. “You must use a validated scale to produce a high level
of evidence.” Ibuprofen and the
narcotic earned very comparable
pain scores (Sundaram H. American Society for Dermatologic
Surgery Annual Meeting. Nov.
3-6, 2011. Washington). Investigators found that for all areas
treated at the 3 mm and 4.5 mm
depths, “Pain scores came down
to a very acceptable level of five or
less, except for the 4.5 mm depth
in the brow area,” where scores
averaged six or seven, she says.
Because studies of other types
of skin treatment show that
patients’ memories of the final
treatment area can color their
assessment of the entire experience, Dr. Sundaram suggests not
treating the brow area last.
The eTwo (Syneron) offers
bipolar fractional radiofrequency
(RF) energy for the dermis and
epidermis. “Often, I will perform
the dermal treatment first,”
she says. Treating the dermis
improves wrinkles and pigmentation and tightens the skin, she
says. “Adding the epidermal
bipolar fractional RF provides
more improvement in pigmentation and improves fine lines,
pores and even telangiectases.”
The ePrime device (Syneron)
uses 32-gauge microneedles to
deliver bipolar RF energy into
the reticular dermis. The treatment stimulates production of
collagen, elastic tissue and HA,
thereby providing volumization
or remodeling of dermis, Dr.
Sundaram says. She has used
the procedure, sometimes with
neuromodulators and fillers, in
patients of color.
The CO2RE laser (Syneron)
provides RF-excited CO2 laser
resurfacing. “The advantage of
the RF-excited technology is that
it enables you to turn the laser
pulse on and off very precisely,”
she says. The laser is tolerated
by all skin types, even in a
highly efficacious fusion mode
combining deep and mediumdepth treatment.
“With some of the older technologies, you can get this little
‘tail’ because there’s a little lag
time in turning off the pulse,” she
says. Because the tail delivers a low
energy level, it does little therapeutically. “But it can generate
enough heat in the skin to potentially cause postinflammatory
hyperpigmentation.” DT
Disclosures: Dr. Sundaram is a
clinical investigator and consultant
for Medicis, Mentor, Merz, Suneva,
Syneron/Candela and Ulthera.
55
56
practice management
Dermatology Times
business consult
60
Elizabeth Woodcock
is the principal of
Woodcock & Associates
and a speaker and writer
specializing in practice
management. Visit
her Web site at www.
elizabethwoodcock.com.
|
May 2012
Aim for accuracy
E&M coding documentation
critical for avoiding audits
Service success
Quality of care can make the difference between good
and great encounters
P
hysicians with the most satisfied patients aren’t necessarily the ones who spend
the most time with patients.
Sometimes, even getting the highestquality goods or services doesn’t make
up for a poor interaction.
Think of staying at a luxurious hotel
with a beautiful view but a surly staff.
You might not rate that experience as
highly as a stay at the friendly, wellkept bed-and-breakfast down the
street.
Are you creating satisfied patients?
Assume that you’ve smoothed many
of the bumps in your practice’s work
flow processes so that patients are not
waiting for significant periods of time,
and let’s take it as a given that you and
your practice are well regarded in the
community. Superior customer service
— the type that turns patients into
advocates for your practice — hinges
on more than just speed and quality,
however.
“There really is no preferred
way of documentation. Any
system is acceptable.”
Quotable
Allan S. Wirtzer, M.D.
Sherman Oaks, Calif.
On accurate E&M coding to avoid CMS audits
See story, page 60
Creating delighted patients is a
daunting proposition, considering the
limited amount of time you spend with
each patient. But it’s not impossible.
Here are 10 strategies to make the
most of each encounter.
Introduce yourself. The patient,
of course, knows who you are — they
have an appointment scheduled with
you — but this act of deference shows
respect and always leaves the patient
with a good impression. When appropriate, offer a handshake or a gentle
touch during this introduction.
Establish rapport. Treat each
encounter as a building block in your
relationship with the patient. Rapport
doesn’t necessarily require an extensive conversation. It may just take one
or two comments — an observation
about a change in the weather, the big
game last weekend, or perhaps an
inquiry about how school is going for
a child. By finding a bit of commonality with the patient, you establish a
measure of camaraderie and trust.
Listen. Of course, you listen
to your patients, but physician,
researcher and author Jerome
→
→
→
DT Extra
Groopman observes that doctors typically interrupt their patients within 18
seconds of the start of a conversation.
For many people, an interruption can
feel like an insult. Try these techniques
to refine your listening and communication techniques with patients:
→ Give the patient the opportunity to talk, then summarize their
thoughts by saying: “Ms. Jones, I
want to make sure that I understood
you correctly. You said …(summarize
complaint).” In two short sentences
you are assuring patients they have
been heard and you are establishing
the agenda for the visit. By coming to
agreement early on about the nature
of the visit, you have the platform to
politely defer any extraneous topics
raised to a future visit.
→ Handle additional, unrelated
issues like a pro. If the patient brings
up additional complaints unrelated to
the chief complaint, stress the need to
give that new issue(s) proper consideration at another visit. For example,
reply: “Mr. Jones, the issue you raise
is so important that I’d like to allow
business consult see page 59
Checklists set task accountability
To ensure exam rooms are in order, determine the
ideal state of every room and develop a checklist to
use at the start of each day. Before clinic starts each
morning, use the checklist to evaluate the readiness
of each room. Assign responsibility for the task to one
person — an assignment that may rotate — or each
physician’s clinical support staff. Using a checklist
to record what needs to be ready will mean you start
off on the right foot, and allows you to establish accountability for tasks.
Source: Elizabeth Woodcock, M.B.A., C.P.C., F.A.C.M.P.E.
May 2012
|
practice management
business consult:
Superior customer service creates satisfied patients from page 56
enough time to thoroughly discuss it
with you. Let’s schedule a follow-up
appointment about that.”
• Use body language to your
advantage. Lean in, not away, when
talking or listening to patients. Make
eye contact and avoid the football
stance, which is sitting down with your
knees apart. It gives the patient the
impression that you’re about to leap
out of your chair. Instead, sit down and
cross your legs. Periodically, take your
hands off the keyboard, or put your pen
down. These actions show the patient
that they are more than a record.
Don’t look at your watch. Yes,
you do have to keep track of time, but
there are polite ways to do so. Hang
a clock behind the head of the exam
table at about eye level when seated.
You can keep your focus on the patient
with the clock also in your line of sight.
To get help with the patients who really
monopolize your time, ask your staff
to page you (on vibrating mode) when
you run more than, say, 30 minutes
behind. One dermatologist told me
he instructed his medical assistant to
knock on the exam room door after
a certain amount of time to say, “Dr.
Gonzalez is on the phone for you.”
Only he and his assistant knew that
Dr. Gonzalez’ first name is “Speedy.”
If you plan to deploy either of these
“get a move on” techniques, be sure to
also have a way to signal your staff that
you really do need more time, such as
telling them to “take a message.”
Use your EHR: Part 1. Instead
of poking your head out the door to
summon a nurse or exploring the
hallways to find a medical assistant,
use the messaging capacities of your
electronic health record system. Alternately, you can simply create your
orders in the EHR with the expectation
that your nurse or medical assistant
will carry them out.
Use your EHR: Part 2. Turn
your EHR and its hardware into an
exam-room located educational
device. Position the computer monitor
on a swivel base so you can share the
information on the screen with the
patient. Even better, install an LCD
panel or flat screen on the wall of the
exam room — 19-inch and 24-inch
screens have become quite affordable.
•
•
•
It can give you a powerful way to show
the patient who’s in for a skin check
what suspicious moles look like, for
example. If appropriate, you may even
share the patient’s record with them on
screen. The personalization possibilities an EHR offers will impress patients
while educating them.
Engage your patients. Waits
and delays often are a result of paperwork. Establish a process by which
your patients can complete medical
history forms online or download them
to complete before appointments.
Your schedulers must be trained to
encourage patients to visit your practice website. They also should collect
an email address along with the other
contact information so the patient can
be sent a link to your website.
In addition to helping patients fill
out registration forms faster, a patient
portal can allow you to channel
appointment requests, medication
renewals and other tasks that formerly
required telephone calls to complete.
If you don’t have access to an online
portal for pre-registration, consider
ways to make the on-site form completion go faster. Hand patients an iPad or
tablet in the reception area on which
to complete their forms, which can
then be automatically fed into your
EHR. Not only will it free your staff
from rekeying information from written
forms (and the ever-present risk of
typos and errors), but front office
employees will have more time to tend
to patients. Your patients will appreciate a smoother, quicker process of
completing registration, medical histories and other forms.
•
• Get the work pulled to you.
The more time you spend between
visits, the less time is left for each
visit. When between patients, don’t
wander around the office looking for
messages, picking up test results,
trying to locate staff and giving orders.
Instead, create a workstation adjacent to the exam rooms you use most
often. Teach staff to gather information and deliver it directly to your
workstation. Set up your workstation
with designated bins or areas specific
to a purpose, such as a “red” bin for
emergencies that you check between
each patient. Designate another bin
for standard messages from patients
or referring physicians, and another
bin to hold test results. Make sure your
staff knows how to take complete and
coherent messages from patients and
referring physicians so that you — and
they — do not waste time making callbacks for clarifying information.
Physicians with the most
satisfied patients aren’t
necessarily the ones
who spend the most
time with patients.
Sometimes, even getting
the highest-quality goods
or services doesn’t
make up for a
poor interaction.
•
Use videos. Computers and
display panels in the exam room
offer the opportunity for patients to
watch educational videos. There are
many commercially available products, but consider taping yourself
explaining what to expect during a
Mohs procedure, for example. If the
patient watches it before or after your
in-person explanation, so much the
better. This reiteration of information
via video helps patient compliance and
allows you a few minutes to slip into the
next room to see another patient who
is in for a quick follow-up check. Some
practices post their dermatologists’
videos on YouTube and encourage
patients to watch them later, too.
As payers put the squeeze on
reimbursements, requiring you to
work faster and see more patients, it
seems that patients are getting more
demanding of your time. While it is
hard to find the happy medium, there
is much you can do to ensure that
patients get superior and respectful
service at each visit. It’s the small
things that transform service from
good to great. DT
59
60
Dermatology Times
practice management
|
May 2012
coding confidence
Attention to documentation, decision-making requirements key to avoiding audits
By John Jesitus
San Diego — Accurately coding for
“If you undercode for
fear of audits, you could
penalize yourself in
terms of reimbursement.”
Allan S. Wirtzer, M.D.
Sherman Oaks, Calif.
E&M services account for the majority
of services rendered by dermatologists
for Medicare patients, Dr. Wirtzer says.
However, if one codes too aggressively
without appropriate supporting documentation, “You could potentially be
targeted for audits,” he says.
Conversely, “If you undercode
for fear of audits, you could penalize
yourself in terms of reimbursement,”
he explains. “Your comfort level with
coding has a profound effect on your
ability to run your practice effectively.”
One key to correct coding is the fact
Abnormal, or not?
Accurate E&M coding not only
maximizes revenues — it
can go a long way toward helping
dermatologists avoid audits.
that “it’s not about what you do or what
you think you did — if it’s not documented, you didn’t do it,” Dr. Wirtzer
says. Some physicians have developed
impressive-looking documentation aids
such as templates or diagrams, he says,
“but not uncommonly, when I review
charts, I’ll notice that these are not filled
in adequately, and as a result, the aids go
to waste.”
By the same token, he says that in
light of the push toward electronic
health record (EHR) adoption, the
Centers for Medicare and Medicaid
Services (CMS) is taking a closer look
at templates used for medical documentation. “It’s easy to use a macro or
template,” Dr. Wirtzer says, “but if it is
not in some way specific to the patient, it
could be judged unacceptable.”
In other words, CMS frowns upon
what it calls production-line documentation systems, Dr. Wirtzer says. “Make
sure your templates can be modified to
take into account the situation at hand
and how the patient is presenting to you.
Sometimes in a record, I will see templates
that contradict each other when you look
at them carefully,” he explains.
To further complicate matters, Dr.
Wirtzer says that according to CMS,
“There really is no preferred way of
documentation. Any system is acceptable,” as long is it satisfies a handful of
conditions that CMS has specified.
However, “You can’t have a notation in the chart of something being
abnormal without elaborating” on the
abnormality, he says. For example, CMS
will reject a notation that a patient’s
lips are abnormal unless the EHR also
indicates in what way they’re abnormal.
“Furthermore, you can’t be too
general with what you say is normal or
abnormal,” Dr. Wirtzer says. “CMS has
specifically said that they don’t particularly like the idea of documenting an
entire organ system as being ‘negative.’”
Dr. Wirtzer says some dermatologists may jot down a phrase such
as “total body exam (sometimes
abbreviated TBE) negative.” However,
he explains, “According to CMS, that’s
unacceptable.”
Instead, CMS prefers that physicians
spell out which portions of an organ
system — or, in the case of dermatology,
which areas of the skin — deviate from
the norm, and how.
Decisions, decisions
The concept of medical decisionCoding confidence see page 60
Doctors: Getty Images/Siri Stafford/Digital Vision; Numbers: Getty Images/Digital Vision/Yagi Studio
evaluation and management (E&M)
services billed to Medicare requires
mastering subtleties that aren’t always
spelled out in coding instructions, said
Allan S. Wirtzer, M.D., medical director,
Mid Valley Dermatology and Cosmetic
Surgery Center, Sherman Oaks, Calif.,
at the 2012 annual meeting of the
American Academy of Dermatology.
62
Dermatology Times
practice management
|
May 2012
coDinG conFiDence:
Accuracy in documentation key to avoiding audits
Another
View
making, a key component of E&M
services, also can be unclear — especially if one relies solely on what the
American Medical Association’s
Current Procedural Terminology
(CPT) manual says about this topic, Dr.
Wirtzer says.
To choose a level of medical decisionmaking for coding purposes, according
to the manual, physicians must consider
the following parameters: the number
of possible diagnoses or treatment
options; the amount and complexity
of data required to make a decision;
and the table of risk associated with
the presenting problem, and with diagnostic options and tests used, as well as
with the physician’s chosen method of
managing the problem.
More specifically, physicians must
make a determination in each of these
areas before choosing a level of medical
decision-making for which to code, Dr.
Wirtzer says, because these parameters
drive one’s ultimate choice in E&M
coding.
Although this may sound complicated, Dr. Wirtzer says he has analyzed
the CPT manual in this area and
distilled it to a relatively simple rubric:
“A single stable or improving condition
is a straightforward level of medical
Mark S. Nestor, M.D., Ph.D., voluntary associate
professor, department of dermatology and cutaneous
surgery, University of Miami Miller School of Medicine, spoke
about contesting an audit at the 2011 annual meeting of the
American Society of Dermatologic Surgery. Here’s some of
what he had to say:
“Fighting an audit is a
huge burden, particularly
for individual physicians …
However, it is a battle worth
fighting by those who know
they are in the right.”
“When we have gone
through the process of appeal,
we’ve won 99.4 percent of
the claims appealed, and
the few exceptions were not
necessarily any different from
the cases won.”
Quick tip
Some dermatologists tend to
undercode for their services for fear of
an audit. Dr. Wirtzer says understanding
the documentation requirements for the
CPT codes, and the modifiers used, will
enable dermatologists to code
confidently and withstand any critical
review of their records.
decision-making. If a patient has one
worsening problem or two active
problems, it’s equivalent to a low level
of decision-making. And if a patient
has a new, undiagnosed problem, the
decision-making is moderate.
“It’s critical that the physician or
his or her staff carefully document the
patient’s history, because the history
portion of the documentation includes
those details that will also determine
the level of decision-making,” he adds.
If documentation of the history
reveals that a patient presented with
both acne and a hand rash that have
improved, “That’s two active problems,
and it’s equivalent to a low level of decision-making,” Dr. Wirtzer says. “No
matter how complex the process seems
by going back to the CPT book, this is
a simple way of determining medical
decision-making.”
Modifier 25
The -25 modifier, which provides separate identification for evaluations of
unrelated problems handled during the
same visit, also has prompted confusion
among physicians, Dr. Wirtzer says.
“This is important because CMS is
sponsoring recovery audit contractor
(RAC) audits,” he says. “Outside
subcontractors are auditing records
and requesting repayment of fees paid
because CMS believes that money has
been paid out inappropriately. The
auditors are being very aggressive in
their attempts to recoup money because
they’re getting a portion of whatever
they recover, like bounty hunters.”
These audits focus specifically on the
-25 modifier, Dr. Wirtzer says, which
dermatologists can use when they
perform an E&M service and a surgical
service at the same visit.
“The auditors are taking a very
critical look at doctors’ records. If there
isn’t what the auditors consider to be a
very significant and separately identifi-
from page 60
able service associated with the E&M
code, they’re not going to allow payment
for it,” he says.
For example, if a patient hasn’t been
seen for awhile and presents with lesions
that are recognized as actinic keratoses
(AKs), “CMS will not pay for a separate
E&M service even though there is a
legitimate argument that the doctor
performed a separate cognitive service
determining the need for a destructive
procedure,” he says.
Therefore, whenever physicians
use the -25 modifier, “They must be
very clear that the service performed
is completely distinct from the surgery
they’re performing,” Dr. Wirtzer says.
For instance, he says that if a patient
presents with numerous AKs — and
the physician must distinguish them
from many other benign lesions on the
patient’s body such as moles or seborrheic keratoses — the doctor should
clearly use the correct International
Classification of Diseases (ICD)-9 codes
to distinguish these other benign lesions
from the AKs.
In this case, “The destruction service
will be correlated with the ICD-9 code
for AKs, and the E&M service will be
associated with the ICD-9 code for
benign lesions,” he explains.
“Dermatologists shouldn’t forget
that sometimes, the time they spend
explaining things to patients will be the
basis for the E&M code they select,” Dr.
Wirtzer adds. “E&M services in which
counseling and/or coordination of care
(account for) more than half of the faceto-face time of the visit may be coded
based on time alone.
“If a patient comes back with an acne
condition that’s not improving, the
CPT code selected based upon the key
components of the examination may
indicate a Level III service,” he says.
However, if during a 25-minute
visit the physician spends a significant
amount of time — which CMS defines
as greater than half the encounter time
— talking about Accutane (isotretinoin,
formerly manufactured by Roche) and
its benefits and risks, “This would be a
Level IV service based on the amount of
time the physician spent with the patient
and/or the patient’s family,” he says. DT
Disclosures: Dr. Wirtzer reports no
relevant financial interests, other than in
the success of his practice, he says.
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64
Dermatology Times
|
May 2012
new products
GalDerma
episciences
Foam wash/moisturizer combats acne
Skin rehab focuses on hydration
The newly-launched Cetaphil DermaControl
Foam Wash and Moisturizer SPF 30 are formulated for acne-prone
skin. Cetaphil DermaControl is designed to
complement an acne
regimen for sensitive,
acne-prone skin.
Delivered through
advanced technology,
the Cetaphil DermaControl skincare system contains
zinc, ceramide and oleosome technologies to help
reduce oil, control shine and support healthy skin by
helping maintain its barrier function and sooth irritation, the company states. Both Cetaphil DermaControl products are gentle, noncomedogenic and have
been clinically tested with common acne medications
for tolerability and performance.
For more information:
www.cetaphil.com
The newly launched Intense Skin Rehab
System is a targeted hydration and barrier
repair kit. The system was
designed to be a takehome regimen following
moderate to deeper skin
rejuvenation procedures.
Comprised of the Epionce
enriched firming mask and
the Epionce medical barrier
cream, the two products
provide a boost of hydration while rapidly restoring
healthy barrier function. They help soothe and calm
highly sensitized skin. Patients using the Intense Skin
Rehab System following ablative laser procedures
recovered five to six days faster than normal postprocedure downtime, the company says. The enriched
firming mask rapidly relieves redness, provides
additional hydration and helps increase elasticity and
firmness in the skin.
www.epionce.com
GlyTone
Peel system targets aging
Glytone introduces its Glytone by Enerpeel
PA peel system (pyruvic acid, 50 percent),
which includes 15 peel systems, for signs of
premature aging and acne. These advanced
single-dose exfoliation peels use a carrier
technology for optimal results. The peel
system delivers better chemoexfoliation with
less surface trauma to minimize fine lines and
wrinkles, reduce acne and provide an immediate glow, according to the company.
Its indications are for seborrhea and comedogenic
acne occurring with seborrhea; actinic keratosis of
moderate severity; fine lines, wrinkles and signs of
chrono- and photoaging; and skin damage due to
environmental factors and/or oxidative stress.
www.glytone-usa.com
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.
Topix pharmaceuTicals
Moisturizing lotion is fortified
Replenix Green Tea antioxidant moisturizing
lotion is a silky, fast-absorbing moisturizer
that helps restore and maintain
a healthy skin barrier function
while preventing transepidermal
water loss. The lotion delivers a
blend of nourishing and protective antioxidants and emollients
to help soften dry skin, according to the company. The lotion
is nontoxic, noncomedogenic,
nonirritating and is free of preservatives, oil, alcohol and fragrances.
The lotion uses such ingredients as green tea
polyphenols, caffeine, resveratrol, hyaluronic acid,
ceramide 2, bisabolol and natural sterols. It contains
selected penetrating lipids, which repair the natural
moisture barrier to provide healing benefits to the skin.
The lotion is ideal for daily use, the company states.
800-445-2595
www.topixpharm.com
nail creaTions
Nail prototype covers toenail loss
A Cleveland barber has a solution to help disguise women’s toenail loss — a nail prototype
designed to cover exposed toes. Maria Barile
engineered Nail Creations, a latex-free adhesive
wrap available online, through physicians’
offices and at several shops. The product
includes 16 adhesive nails in assorted sizes.
The product is designed to allow wearers to put
on the wrap, add nail polish, and then remove
the product when desired. The “nail” can be
worn for up to two days. Nail Creations is not a
medical device,
but a temporary, cosmetic
adhesive cover.
Companies
interested in selling the product
wholesale can
contact NailCreations at its website.
www.appealingwhilehealing.com
www.facebook.com/NailCreations1
polloGen
Skin system contours body
The apollo system is an aesthetic solution based
on TriPollar radiofrequency technology. It helps to
safely and effectively contour the face and body,
according to the company.
The treatment is noninvasive,
painless, and is effective on
all skin types. The focused energy eliminates the need for a
cooling mechanism, the company states. The office-based
treatment offers immediate
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The system addresses localized fat reduction, circumference reduction, facial
contouring, fine lines and wrinkle reduction, skin tightening, improved décolletage and stretch marks.
877-701-2699
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molesafe
Melanoma screening diagnoses early
MoleSafe, an advanced melanoma screening
program, helps diagnose melanoma at the
earliest possible stage and provides a complete digital record of
the skin down to the
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The digital record of
the patient’s skin becomes the baseline
by which changes to
moles may be identified on follow-ups.
Utilizing skin surface epiluminescence microscopy
(dermoscopy), lesions are digitally imaged, archived
and linked to the relevant body location. The patient’s
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1
SKINmed: Dermatology for the Clinician, April 2010. 22011 Survey conducted by Merz Pharmaceuticals, LLC
After 12 weeks
66
Dermatology Times
calendar
Product
American Dermoscopy
upcoming
events
American Safety Razor - Personna
Dermatology Times lists meeting
announcements for the following three
months in our print issue.
For a full listing of events, go to www.dermatologytimes.com
www.mohscollege.org
May 3-6, 2012
Fairmont Hotel
Chicago
May 2012
ad index
Advertiser
American College of Mohs
Surgery 44th Mohs College
Annual Meeting
|
Dannemiller and American
Dermoscopy Meeting
www.americandermoscopy.com
June 22-23, 2012
Four Seasons Resort
Jackson Hole, Wyo.
Page
55
DermaBlade
045
Aqua Pharmaceuticals
Monodox
7
Bayer Dermatology
Corporate
5
Eucerin
33
Beiersdorf
Ceptaris Therapeutics Inc
15
Connectivision
35
Coria Labs
Retin-A
CV2-3
Dusa Pharmaceuticals Inc
Levulan
12-13
Galderma Laboratories Inc
Cetaphil
CV3
International Dermoscopy
Society 3rd World Congress
of Dermoscopy
International Federation of
Psoriasis Assocations 3rd
World Psoriasis & Psoriatic
Arthritis Conference
www.dermoscopycongress2012.org
May 17-19, 2012
Brisbane Convention & Exhibition Center
Brisbane, Australia
http://ifpaworldconference.com
June 27-July1, 2012
Stockholm Waterfront Congress Centre
Stockholm, Sweden
Differin
57-58
Epiduo
47-48
Australasian College of
Dermatologists 45th Annual
Scientific Meeting
Society of Dermatology
Physician Assistants
Summer Dermatology
Conference
Oracea
37-38
Genentech Inc
Erivedge
21-22
www.dermcoll.asn.au
May 20-23, 2012
Brisbane Convention & Exhibition Center
Brisbane, Australia
www.dermpa.org
July 11-15, 2012
The Westin Seattle
Seattle
American Society for Mohs
Surgery Dermatologic
Surgery: Focus on Skin
Cancer
Society for Pediatric
Dermatology 38th
Annual Meeting
www.mohssurgery.org
May 24-27, 2012
Sheraton Wild Horse Pass Resort & Spa
Chandler, Ariz.
Georgia Society of
Dermatology &
Dermatologic Surgery
57th Annual Meeting
www.gaderm.org
June 1-3, 2012
Westin Hilton Head Island Resort & Spa
Hilton Head Island, S.C.
Chinese Society of
Dermatology 3rd World
Congress on
Genodermatology
www.cmacsd.org/wcg2012/
June 12-14, 2012
China National Convention Center
Beijing
Alabama Dermatology
Society Summer
Symposium
www.alabamaderm.org
June 21-24, 2012
Sandestin Hilton Hotel
Sandestin, Fla.
La Roche Posay
25
Medical Technology
43
Merz Pharmaceuticals
Mederma
65
www.pedsderm.net
July 12-15, 2012
Portola Hotel & Spa at Monterey Bay
Monterey, Calif.
Merz Pharmaceuticals
Naftin
27-28
North Carolina Dermatology
Association 2012 Annual
Meeting
Palomar Medical Technologies
Pacific Bioscience Laboratories
09
Icon
CV4
Pharmaderm
Apexicon E Cream
51-52
Pharmaderm
Veregen
41-42
8th Annual Cosmetic
Bootcamp
Promius Pharmaceuticals
Promiseb
Cover Tip
www.cosmeticbootcamp.com
July 19-22, 2012
Broadmoor Resort
Colorado Springs, Colo.
Ranbaxy Pharmaceuticals Inc
Halog
11
Ranbaxy Pharmaceuticals Inc
Kenalog
31
National Medical
Association 2012 Annual
Convention & Scientific
Assembly
Revision Skincare
Teamine
61
Spear Dermatology
Refissa
53-54
Valeant Dermatology
Acanya
17-18
www.ncmedsoc.org
July 13-15, 2012
The Homestead
Hot Springs, Va.
www.nmanet.org
July 28-Aug. 1, 2012
New Orleans Convention Center
New Orleans, La.
ZO Skin Health
63
This index is provided as an additional service. The publisher
does not assume any liability for errors or omissions.
May 2012
|
67
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education
ASMS
Search
American Society for Mohs Surgery
Upcoming CME Activities
Annual Clinical Symposium – Dermatologic
Surgery: Focus on Skin Cancer
Closures Course and Fundamentals of Mohs
Surgery
November 5 - 7, 2012 – Closures Course for Dermatologists
Course prerequisite is basic experience in cutting and sewing skin, and program is
designed to take dermatologists to the next level of dermatologic surgery practice.
This is an intense 2-day experience in closure considerations for the surgeon with
a primary interest in closing surgical defects. It will feature practical techniques,
site specific discussions, and numerous reconstruction “pearls,” based upon
presenters’ extensive derm surgery experience.
Memorial Day Weekend, May 24 - 27, 2012
Sheraton Wild Horse Pass Resort & Spa –
Chandler, Arizona
Top experts in the field will provide updates on a wide range of
dermatologic surgery and Mohs surgery topics. Separate interactive
panels will discuss appropriate repair strategies for a variety of
surgical wounds and innovative approaches to melanoma treatment.
Both Mohs and non-Mohs cases will be featured in the microscope
laboratory. Mohs nursing staff, technicians and other Mohs support
personnel will increase their knowledge of skin cancer treatment
and develop a greater appreciation for their unique roles in supporting
high quality dermatologic care.
AMA PRA Category 1 Credit Available
For additional information regarding ASMS educational activities,
membership opportunities, and patient resources, please contact:
Novella Rodgers, Executive Director
American Society for Mohs Surgery
5901 Warner Avenue, Box 391
Huntington Beach, CA 92649-4659
Tel: 800-616-2767 or 714-379-6262
Fax: 714-379-6272
www.mohssurgery.org
execdir@mohssurgery.org
November 8 - 11, 2012 – Fundamentals of Mohs Surgery for
Dermatologists and Mohs Technicians
Developed as a comprehensive introduction to Mohs surgery, the course
provides an overview of Mohs indications, mapping techniques, office set-up
and instrumentation, and interpretation of Mohs histopathology. Instruction in
key concepts is facilitated by lectures, “pearls” discussions, interactive Q&A
sessions, video microscope demonstrations, and challenging microscope electives.
The Mohs technician program will feature hands-on training in Mohs laboratory
techniques and incorporate important safety and regulatory guidelines and
updates. A high faculty-to-student ratio helps ensure rapid skill development
and advancement, and allows for discussion of critical troubleshooting techniques
relative to tissue processing and slide preparation.
AMA PRA Category 1 Credit Available
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May 2012
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Marketplace
Dermatology Times |
May 2012
products & services
office space available
practice for sale
OFFICE FOR SUBLEASE/SHARE NYC
Upper East Side Medical Office
AAASC Certified
Includes 2 Exam Rooms,
Reception & Operatory
Perfect for a Dermatologist
For more information contact:
lystia7@gmail.com
practice for sale
national
PRACTICE SALES
& APPRAISAL
oregon
Suburban North Atlanta.
Practice for Sale
Fee for Service Dermatology Practice for Sale.
Branded Name. Affluent equestrian, lake, and golf
community. Top public and private schools. 4500 active
charts, 2500 monthly newsletter participants, high
organic internet search placement. Highly experienced
sales and medical staff are eager to assist in transition.
Equal balance of medical and cosmetic services offered.
Equipment included in the sale: all office furnishings
in the 3000 square foot office, 5 equipped examination
rooms/surgical suites, sterilization area, 1 Fraxel SR
1500 laser, 3 Thermage Radiofrequency Devices,
1 Liposonix HIFU system, 1 Zimmer Cooler system,
1 Silk Peel Microinfusion system, 5 Station Computer
System with 7 Provider Office Hours Software, branded
lobby loop plasma TV advertising program, passive retail
product sales area generating $5000-8000/month,
branded website coded for new provider. $700,000.
For more information, please contact Mr. Ross
at spikeproperties@gmail.com
Expert Services for:
Buying or Selling a Practice
Practice Appraisal
Practice Financing
Partner Buy-in or Buy-out
64 YO Mohs surgeon / dermatologist
contemplating retirement in 6-18 months.
Looking for someone who enjoys a
combination of Mohs, reconstruction,
lasers, cosmetic and general derm. I have
a productive PA and a loyal staff. It would
be great if that staff still had a place to work
after I retire. We are a few minutes from
Portland, Oregon, land of biking, hiking,
beautiful scenery and a relaxed lifestyle.
Principals only.
Please respond to
pgoodkin1@aol.com
www.GoodSkinMD.com
Peter Goodkin
kentucky
PRACTICE FOR SALE OR LEASE
E L I Z ABE T H T O W N , K E N T U C K Y
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.
Call for a Free Consultation
(800) 416-2055
www.TransitionConsultants.com
We Buy Practices
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georgia
Call Karen Gerome
to place your
Products
& Services
FREE
SPACE ad at
1 col x 2
800.225.4569
ext. 2670
kgerome@advanstar.com
Available at (877) 769-6327 derma@windstream.net
or (423) 821-8230 jmgalex@epbfi.com
Retiring
Monetization of your practice
Locking in your value now
Succession planning
Sell all or part of your practice
products
Please call Jeff Queen toll free at
(866) 488-4100 or
email WeBuy@MyDermGroup.com
www.MyDermGroup.com
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May 2012
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Marketplace
recruitMent
california
florida
pennsylvania
BC/BE Dermatologist and/or
Mohs Surgeon Needed in Las Vegas
We seek a dynamic
Northeast PeNNsyLvaNia
Very Competitive salary & benefits.
Excellent opportunity.
Please send CV to: michelle@lalasercenter.com
florida
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
SARASOTA BAYFRONT
• Growing Dermatology Practice
• Ready for Associate
• Medical/Surgical/Cosmetic
“Practice like you dreamed about”
Fax (941)951-1966
DERMATOLOGIST
OPPORTUNITY IN FLORIDA
(between Tampa and Orlando)
Financially stable multi-specialty group seeks a
BE/BC Dermatologist to join our existing collegial
group of 6 Dermatologists, 2 Dermatopathologists
and Mohs surgeon. Option to read your own slides.
•ExtensiveservicesIn-house(lab,radiology
includingMRIandCT,phototherapywith
UVB&PUVA)
•MedicalSpa
•200+physician-ownedandrunpractice;
40specialties
•Verycompetitive1styrsalaryguarantee+
bonus;Partnershipafter2yrs
•Extensivebenefitswithprofessionalliability
insurance&relocationassistance
•Exceptionalsuburbansettingwithexcellent
reimbursement
•Abundantrecreationyearround–500+lakes
andnumerousparks;within45minutesof
Orlando&Tampaattractions
•NO STATE INCOME TAX!
WATSON CLINIC LLP
1600 Lakeland Hills Blvd. Lakeland, FL 33805
800-854-7786 • Fax 863-680-7951
email: wgonzalez2@watsonclinic.com
BC/BE Mohs Surgeon and
General Dermatologist
to join our progressive, young practice.
This is a full time opportunity with the
potential to earn an equity interest in
the practice in Southwest Florida. Our
dermatology practice provides general
& cosmetic dermatology, Mohs surgery,
in house pathology, and much more.
In addition, we provide insurance
benefits, malpractice coverage and
great compensation package.
Busy dermatology practice seeks
BE/BC dermatologist for our 32 year old, four
physician, four physician assistant practice.
General dermatology and subspecialty interest
welcomed. Excellent compensation, benefits
and partnership opportunity.
www.lackawannadermatology.com.
Please contact
Kathryn Colombo, Practice Manager at
Lackaderm@aol.com or by fax 570-207-5579
Email: recruit2068@gmail.com
BC/BE Dermatologist
PENNSYLVANIA
illinois
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.
Dermatologist BC/Bs
ottawa, illinois
Busy Practice - 1 Hour from Chicago
Please Call Lori 708-460-7890
Fax Resume 708-460-5537
Email: swderm@yahoo.com
Call Bonnie Oberholtzer at
(717) 509-5968
or e-mail to: blo@dermlanc.com
new jersey
Dermatologist
tennessee
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
new york
E
B
C/
B
Scenic S.E. city on
the TN River offers
wonderful recreation
and cultural activities
4 busy midlevel providers, Mohs, Histolab
Full partnership and earnings of 1.5 mil after
P/T Dermatopathologist
for practice in
Nassau County, N. Y.
Please fax CV to: 516-482-6039
or email: yelka_enjedi@hotmail.com
3 years. No out of pocket buy in
Email - stcydaily@yahoo.com
Fax - 423-899-2703
virginia
RICHMOND, VA
Call Jacqueline Moran
to place your Recruitment ad at
800.225.4569, ext. 2762
jmoran@advanstar.com
Opportunity available in historic
Richmond, VA. Well-established practice
seeking BC/BE General/Surgical/
Cosmetic dermatologist.
State-of-the-art facility. Excellent benefits,
malpractice, health insurance.
Email CV to mpalmer@richmonddermlaser.com
73
74
Dermatology Times |
May 2012
physician’s profile
John E. Olerud, M.D.
Born:
Fargo, N.D., 1943
Medical degree:
University of Washington, Seattle
Internship:
University of Washington
Residencies, internal medicine
and dermatology:
University of Washington
Hobbies: Baseball, golf, photography
Family: Wife, Lynda Olerud;
son, John G. Olerud; daughter,
Erica Olerud; and three grandchildren
John E. Olerud, M.D., holding his son in Albuquerque, New Mexico, after a game in 1970.
(Photo: John E. Olerud, M.D.)
Up to bat
From baseball to dermatology, physician stays
on top of his game with talent, passion
In His Own Words:
What is the best professional advice
you ever received?
While playing for WSU under coach Chuck
“Bobo” Brayton, Dr. Olerud says he learned these
important lessons about life: Take pride in your
organization, pride in your country and pride in
the work you do. Don’t let anyone outwork you.
Don’t let anyone be better prepared than you are.
A swinging bat is a dangerous bat. If you’re not
swinging a bat, you’re not going to get any hits.
Over a long period of time, excellence and quality
are the most important things to come out of an
organization.
By lisette Hilton
Staff Correspondent
A
ccording to dermatologist
John E. Olerud, M.D., “Life is a lot
like baseball.”
In fact, Dr. Olerud often shares
with his trainees the life lessons he learned as
a professional baseball player. He focused on
the topic in a recent acceptance speech, when
Washington State University honored him last
year with its Regents’ Distinguished Alumnus
Award. And the dermatologist’s beloved sport
remains a part of his daily teaching.
“My poor residents have to listen to all the
metaphors about baseball,” he says.
Baseball is a topic near and dear to Dr.
Olerud. While earning his undergraduate degree
at Washington State University during the mid1960s, he was team captain and catcher for the
WSU Cougars. The team went to the College
World Series, and Dr. Olerud was named to the
All-American Team.
He continued a career in baseball while
attending medical school at University of Washington, Seattle, playing professional ball every
summer. After six years of medical school and
seven summers playing in the minor leagues
for such clubs as the Seattle Angels, San Jose
Bees, El Paso Sun Kings, Tulsa Oilers and Win-
nipeg Whips, Dr. Olerud pursued a career in
dermatology.
“Baseball was my first passion and medicine
was what I knew I’d do in the long term,” he says.
“If I had been as good a ballplayer as my son, I
probably would have played as long as I could.”
After Dr. Olerud’s successful run in the sport,
he lived vicariously through his son, John G.
Olerud, who made his mark as a major league
first baseman. From 1989 to 2005, John Olerud
played professionally for the Toronto Blue Jays,
New York Mets, Seattle Mariners, New York
Yankees and Boston Red Sox. A three-time Gold
Glove winner, John Olerud won the American
League batting title in 1993, and he was runnerup for the National League batting title in 1998.
From sports to medicine
Dr. Olerud’s claim to fame in dermatology is
a focus on teaching and research. Head of
the dermatology program at the University of
Washington, he says he is proud of the school’s
dermatology training program.
His research, especially in wound healing,
has resulted in more than 90 publications and
several government and other grants. His main
area of research is diabetic wound healing and
developing models to study wound healing. His
clinical research and publications have been in
T-cell lymphoma.
Still time for baseball
Dr. Olerud never lost his competitive nature on
the field. He catches for a team in the Seattle
area, which year after year wins the Roy Hobbs
adult amateur World Series in Florida.
“We have quite a bunch of ball players up
here that won’t give it up,” he says. “I was a
catcher then and am still a catcher.”
While his goal on the field might be to keep
winning the World Series, Dr. Olerud, who is a
past-president of the Association of Professors
of Dermatology, says his approach in dermatology can be summarized in the movie line, “If
you build it, they (residents) will come.”
“We’ve been trying to create an environment
at University of Washington where young people
can succeed and become leaders in clinical
and academic dermatology,” he says. “I’m
hoping that when I hand the division off to the
next generation, it’s in better shape than it was
when I received it. And I hope this will continue
to be thought of as an outstanding dermatology
program.” DT
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References: 1. Data on file. Galderma Laboratories. 2. Bigotti C, Guala F, Merlo E, Gazzaniga G, Villa G. Zinc and its derivatives:
their applications in cosmetic. J Appl Cosmetol. 2005;23:139-147. 3. Rigano L, Merlo E, Guala F, Villa G. Stabilized solutions of zinc
coceth sulfate for skin cleansing and skin care. Cosmetics Toiletries. 2005;120:103-108. 4. Schwartz JR, Marsh RG, Draelos ZD.
Zinc and skin health: overview of physiology and pharmacology. Dermatol Surg. 2005;31:837-847. 5. Castiel-Higounenc I,
Chopart M, Ferraris C. Stratum corneum lipids: specificity, role, deficiencies and modulation. OCL. 2004;11(6):401-406.
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