A Randomized Controlled Clinical Study to Evaluate the

October 2014
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Volume 13 • Issue 10
Copyright © 2014
ORIGINAL ARTICLES
SPECIAL TOPIC
Journal of Drugs in Dermatology
A Randomized Controlled Clinical Study to Evaluate
the Effectiveness of an Active Moisturizing Lotion With
Colloidal Oatmeal Skin Protectant Versus Its Vehicle
for the Relief of Xerosis
Amer N. Kalaaji, MDa and Warren Wallo, MSb
Department of Dermatology and Division of Anatomic Pathology, Mayo Clinic, Rochester, MN
b
Scientific Affairs Department, Johnson & Johnson Consumer Products Company, Skillman, NJ
a
*The use of brand names does not imply endorsement by Mayo Clinic.
ABSTRACT
Xerosis is a common skin condition, occurring most often in the winter and in low relative humidity, which results in loss of moisture,
cracking, and desquamation. Many emollient creams and lotions are available for use as preventive moisturizers. However, few controlled experiments have been published comparing the efficacy of active moisturizing products versus the vehicle used to deliver
the products to the skin. Therefore, we conducted this randomized, double-blind, controlled clinical study to objectively compare a
commercially available moisturizing product against its own vehicle. The active colloidal oatmeal moisturizer used in this study showed
significant benefits versus its vehicle control in several dermatological parameters used to measure skin dryness.
J Drugs Dermatol. 2014;13(10):1265-1268.
INTRODUCTION
X
erosis is a major cause of pruritus, particularly in climates with low humidity or cold temperatures and in
older persons. When skin is extremely dry, excessive
flaking of corneocytes can cause the formation of microfissures
and an increase in mast cells and histamine levels, which results
in chronic itch.1,2 Although many available topical products can
provide patients with moisturizing benefits, few well-controlled
clinical studies have been conducted that demonstrate significant benefits of specific active compounds.3,4,5 We performed a
randomized, controlled clinical study to address this deficiency
in the literature. We aimed to compare the moisturizing abilities
of the active ingredient in a commercially available colloidal
oatmeal skin protectant with its vehicle lotion.
METHODS
This study was approved by the Mayo Clinic Institutional
Review Board. Patients seen in the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, were recruited to
participate in the study between December 2011 and April
2012. Thirty women aged 18 to 70 years with bilateral moderate to severe xerosis and bilateral mild to moderate pruritus
on the lower legs were enrolled. All patients who agreed to
participate provided informed consent. For all potential subjects, the skin on their lower legs was clinically graded at a
preliminary visit. Eligible subjects needed to have bilateral
moderate to severe dryness (scores of 2-4 on a 0-4 skin dryness scale) and bilateral mild to moderate itch (scores of 1-2
on a 0-3 subjective itching scale) on both lower legs. Subjects
were excluded from the study if they had active dermatitis or
other skin disease involved on their legs.
All enrolled subjects were instructed to refrain from using any
leave-on products on their lower legs for the 5 days before the
start of the study. During the first study visit (baseline, day 0),
each subject was assigned to use both test products in a bilateral study design: one product labeled as “A,” to be used on
the right leg, and the other labeled as “B,” to be used on the
left leg. The 2 test products were a commercially available skin
relief moisturizing lotion with colloidal oatmeal skin protectant
(Aveeno Skin Relief Moisturizing Lotion, Johnson & Johnson
CCI) and its matching vehicle lotion (provided by Johnson &
Johnson CCI). Both the subjects and the clinical investigator
were blinded as to the identity of products “A” and “B,” which
was randomized for each patient. Subjects were instructed to
apply the products to the lower legs twice daily and continue
with this application regimen for 3 weeks, then discontinue all
treatments for 1 more week.
Clinical Evaluations
Test sites on the lower legs of each of the subjects were graded
clinically by the author (A.N.K.). Grading was done at baseline
(day 0), after 21 days of treatment, and after a 1-week regression period without treatment (day 28). Scaling and cracking of
the skin were graded on a scale of 0 (no scaling or cracking) to 9
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October 2014 • Volume 13 • Issue 10
(the most severe scaling or cracking). Overall dryness was evaluated using a skin dryness scale of 0 (no scaling) to 4 (severe
scaling/fissuring). The patients were also interviewed to rate the
intensity, duration, and frequency of their itch on a subjective
itching scale of 0 (no itch) to 3 (most intense itch).
A. N. Kalaaji, W. Wallo
TABLE 1.
Clinical Grading
Active Moisturizing
Lotion (N=30)
Vehicle Lotion
(Control) (N=30)
Instrumental Measurements
Day 0
5.47
5.47
The products’ effect on the skin surface at the test sites was
measured by using 2 instruments: the Corneometer CM 825
(Courage + Khazaka electronic GmbH) and the Skicon 200EX
(Acaderm). These instruments quantify moisture content in the
stratum corneum by an electrical method. The Corneometer
measures capacitance in Corneometer units, and the Skicon
measurements are made in microsiemens, the SI unit for electrical conductance and the reciprocal of electrical resistance.
Three replicate measurements were taken on each lower lateral
leg at the midpoint between the knee and ankle. Measurements
were made at each of the 3 visits.
Day 21
0.8
1.34
−4.67
−4.13
A high-definition microscope (HI-Scope Advanced KH-3000
Video Microscope System, HiroxUSA) also was used to capture x100 magnification images of the skin in a dimension
of approximately 2x3 mm at the designated sites. Test areas
were marked by the study coordinator and marked again as
needed to ensure that the same site was imaged during each
session. HI-Scope images were obtained for several patients
on each lower lateral leg, in an area with minimal hair, at baseline, day 21, and day 28.
Self-Assessment
Subjects completed a self-assessment questionnaire at baseline,
day 21, and day 28. Subjects rated the condition of the skin on
each of their lower legs and expressed their preferences about
which product, A or B, was more effective for several parameters.
Clinical Grading
Scalinga
RESULTS
Clinical Evaluations
After 21 days of treatment, the changes from baseline value
for the parameters of scaling and overall dryness were significantly greater for the active moisturizer than its vehicle (P=.03
and P=.004, respectively; Table 1). The subjects were asked to
grade the intensity, duration, and frequency of their itch at both
test sites, using a 0 to 3 scale for each parameter. The average
.03
Change
.004
Overall dryness
b
Day 0
2.52
2.52
Day 21
0.3
0.65
Change
−2.22
−1.87
Mean score of all subjects; score on a 0-9 scale.
b
Mean score of all subjects; score on a 0-3 scale.
a
TABLE 2.
Patients’ Ratings of Intensity, Duration, and Frequency of
Itch Before and After Lotion Use
Active Moisturizing
Lotion (N=30)
Vehicle Lotion
(Control) (N=30)
Day 0
1.53
1.57
Day 21
0.20
0.53
Change
−1.33
−1.04
Decrease
87%
66%
Day 0
1.57
1.50
Day 21
0.20
0.53
Change
−1.37
−0.97
Decrease
87%
64%
Day 0
2.10
2.13
Day 21
0.23
0.63
Change
−1.87
−1.50
Decrease
89%
70%
Parametera
Intensity of itch
Duration of itch
Statistical Analysis
All data were collected in a blinded fashion by the clinical investigator and given to the nonclinical investigator for transmission
to an independent statistician for unblinding and data analysis.
Mean differences in values between products were compared
using paired t tests. Changes from baseline for each product
were also tested using paired t tests. Proportions were compared using the McNemar test. Preferences were tested using
the binomial test. P<.05 was considered statistically significant.
P
Value
Frequency of itch
a
All parameters were rated on a 0-3 scale. Means for all patients are shown.
grades reported for active moisturizing lotion and vehicle lotion
at baseline and after 21 days of treatment are shown in Table 2,
along with the change in grade and the percentage decrease.
The active moisturizer was perceived as better at relieving itch
than the vehicle alone.
Instrumental Measurements
Figure 1 shows the average hydration values measured by the
Corneometer and Skicon instruments at baseline (day 0), day
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October 2014 • Volume 13 • Issue 10
FIGURE 1. Skin Hydration Measurements. The active moisturizing
lotion (white bars) is compared with the vehicle (black bars). A
larger number indicates more hydration. a) Measurements with the
Corneometer CM 825. b) Measurements with the Skicon 200EX.
a)
A. N. Kalaaji, W. Wallo
FIGURE 2. Change in Skin Hydration Measurements. Values shown
are the result of subtracting the baseline values from the values at
day 21 and day 28 for the active moisturizing lotion (white bars) and
the vehicle (black bars). A larger number indicates greater change in
hydration. a) Measurements with the Corneometer CM 825. b) Measurements with the Skicon 200EX.
a)
b)
b)
21, and day 28 (after the 1-week regression). At day 21 and day
28, the measurements were significantly higher (P<.05) for the
active moisturizing lotion than the vehicle, indicating better
hydration. Figure 2 shows the change versus baseline for both
the Corneometer and Skicon at day 21 and day 28. The average change in moisturization was significantly greater (P<.05)
for the active moisturizing lotion than the vehicle. There was
also a considerable decrease in hydration for both lotions during the regression phase.
Videomicroscope Images
HI-Scope images were taken of a small area on each lower
lateral leg of several subjects at baseline, day 21, and day 28.
An example from one patient shows that both areas demonstrated xerosis at baseline (Figure 3A). After 21 days of
treatment, however, the leg treated with the active moisturizing lotion showed marked improvement over the leg treated
with the vehicle (Figure 3B). Even after the 1-week regression
period, the area treated with the active moisturizing lotion
still displayed fewer signs of xerosis than the area treated
with the vehicle (Figure 3C).
Self-Assessment
After 21 days of treatment, all 30 patients stated which lotion,
A or B, they preferred for different parameters. After the data
were unblinded, indicating which leg had which lotion for each
patient, it became evident that considerably more patients expressed a preference for the active moisturizing lotion over
the vehicle for all parameters (Table 3).
DISCUSSION
Xerosis and pruritus are together a major field of study within
dermatology, and many products have been researched and
manufactured in an attempt to bring relief to the millions of
patients affected by these conditions. In particular, many topical
products are designed to both moisturize the skin and relieve
itching. However, despite many studies that aimed to prove the
efficacy of these products, few have demonstrated that the active ingredients of these products have any significant benefits
when compared with their own vehicle. This study was conducted in an attempt to amend this oversight.
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October 2014 • Volume 13 • Issue 10
FIGURE 3. HI-Scope Images of a Small Area on the Lower Lateral Legs
of One of the Test Subjects. (Original magnification, ×100.) One leg was
treated with the active moisturizing lotion (left images) and the other
was treated with only the vehicle (right images). a) Baseline. b) After
21 days of treatment. c) After the 1-week regression period (day 28).
A. N. Kalaaji, W. Wallo
TABLE 3.
Self-Assessment of Patient Preferences
Preferred Lotiona
Active
Moisturizing
Lotion
Vehicle
Lotion
(Control)
Better overall appearance
26 (87)
4 (13)
Less itchy
25 (83)
5 (17)
Less dry
26 (87)
4 (13)
Softer and smoother
26 (87)
4 (13)
Less irritated/more comfortable
26 (87)
4 (13)
Feels more moisturized
26 (87)
4 (13)
Preference on Day 21
a)
a
b)
Number (%) of patients who preferred each lotion.
gredients in a skin care product have the actual effect promised
and are more effective than the vehicle. These results are especially important for dermatologists to make informed product
recommendations to their patients. Further examination of the
active ingredients in skin care products to ensure their efficacy
should be an area of focused research in the future.
ACKNOWLEDGMENTS
c)
The authors thank Michael Suero (Johnson & Johnson CCI) for
technical contributions, David Lewin (Statistically Speaking,
LLC) for statistical analysis, and Kristopher De Young (Kaztronix, LLC) for his assistance in manuscript preparation.
DISCLOSURES
The article was funded by Johnson & Johnson CCI. The authors
have no relevant conflicts of interest to declare.
REFERENCES
During this study, the active moisturizing lotion with colloidal
oatmeal skin protectant showed significant benefits over its vehicle lotion control in several key dermatological parameters.
Double-blinded, clinical grading by a dermatologist demonstrated that the active moisturizing lotion had significantly
greater improvements from baseline than the vehicle for the
parameters of scaling, overall dryness, and intensity, duration,
and frequency of itch. In addition, the active moisturizing lotion demonstrated significantly better hydration as measured
by the Corneometer and Skicon at 21 and again at 28 days (after
the 1-week regression). Furthermore, the self-assessments also
demonstrated that patients favored the active moisturizing lotion on almost all tested attributes.
These results support that the active ingredient in this particular
moisturizing product is, in fact, beneficial to the skin and assists
in maintaining proper hydration of the skin and in the prevention of pruritus. It is valuable for the practicing dermatologist to
have clear evidence-based results showing that the active in-
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AUTHOR CORRESPONDENCE
Amer N. Kalaaji MD
E-mail:................……................................... kalaaji.amer@mayo.edu