Download A Randomized Controlled Clinical Study to Evaluate the

ePoster 1241
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
aAmer
N. Kalaaji, MD; bWarren Wallo, MS
a Mayo
Clinic Department of Dermatology, Rochester, MN
bScientific Affairs Department, Johnson & Johnson Consumer Products
Company, Skillman, NJ
Research supported by a grant from Johnson & Johnson CCI.
©2015 MFMER | slide-1
Disclosures
• The research was funded by a grant from
Johnson & Johnson CCI.
• Dr. Kalaaji has no relevant conflicts of interest
to declare.
• Mr. Wallo was an employee of Johnson &
Johnson at the time of the research.
©2015 MFMER | slide-2
Abstract
• Background: Xerosis is a common skin condition, resulting in loss of moisture, cracking, and
desquamation.
• Objective: To compare a commercially available moisturizing product against its own vehicle in
patients with bilateral xerosis of the lower legs
• Methods: Subjects applied product or vehicle twice daily in a randomized, bilateral design over a
three week period, followed by one week of regression. Dermatological assessments, objective
instrumental biophysical measurements and patient self-assessments were performed at
baseline, 3 weeks, and after 1 week regression.
• Results: 30 female subjects completed the study. The active moisturizing lotion had significantly
greater improvements from baseline than the vehicle for scaling, overall dryness, as well as
intensity, duration, and frequency of itch. The active moisturizing lotion demonstrated
significantly better hydration as measured by the Corneometer and SkiCon instrumentation at 21
and again at 28 days. Patients favored the active moisturizing lotion.
• Conclusions: The active ingredients in the moisturizing lotion are more effective than the vehicle.
©2015 MFMER | slide-3
Methods
• Clinical evaluations:
• Test sites on the lower legs of each of the
subjects were graded at baseline (Visit 1,
day 0), after 21 days of treatment (Visit 2),
and after one week regression without
treatment (Visit 3, day 28).
• Scaling was graded on a scale of 0-9.
• Overall dryness was evaluated using a 0-4
scale.
• The intensity, duration and frequency of their
itch on a 0-3 scale.
©2015 MFMER | slide-4
Methods
• Instrumental measurements:
• Corneometer and the SkiCon instruments were
used to quantify moisture content in the stratum
corneum by an electrical method.
• Three replicate measurements were taken on
each lower lateral leg midpoint between the
knee and ankle at each of the three visits.
©2015 MFMER | slide-5
Methods
• Self Assessment:
• Subjects completed a self assessment
questionnaire at Baseline (Day 0), Day 21,
and Day 28.
• Subjects rated the condition of the skin on
each of their lower legs and expressed their
preferences as to which product was more
effective for a number of parameters.
©2015 MFMER | slide-6
Methods
• Statistical analysis:
• Mean difference between products were
compared using paired t-tests. Changes
from baseline for a product were tested using
paired t-tests. Proportions were compared
using McNemar’s test. Preferences were
tested using the binomial test.
• P<0.05 was considered statistically
significant.
©2015 MFMER | slide-7
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=0.03 and P=0.004, respectively).
©2015 MFMER | slide-8
Results
• Clinical evaluations
• The active moisturizer was perceived as
better at relieving itch than the vehicle alone.
©2015 MFMER | slide-9
Results
• Instrumental measurements
• At day 21 and day 28, the measurements
were significantly higher (P<0.05) for the
active moisturizing lotion than the vehicle,
indicating better hydration.
• The average change in moisturization was
significantly greater (P<0.05) for the active
moisturizing lotion than the vehicle.
• There was also a considerable decrease in
hydration for both lotions during the
regression phase.
©2015 MFMER | slide-10
Results
• Instrumental measures
Measurements with the Corneometer.
Measurements with the SkiCon
The active moisturizing lotion (white bars) is compared
with the vehicle (black bars). A larger number indicates
more hydration.
The active moisturizing lotion (white bars) is compared with
the vehicle (black bars). A larger number indicates more
hydration.
©2015 MFMER | slide-11
Results
• Videomicroscopic images
• Example from one patient shows
xerosis at baseline (A).
• After 21 days of treatment (B), the
leg treated with the active
moisturizing lotion showed marked
improvement over the leg treated
with the vehicle.
• Even after the 1-week regression
period (C), the area treated with
the active moisturizing lotion still
displayed fewer signs of xerosis
than the area treated with the
vehicle.
©2015 MFMER | slide-12
Results
• Self-Assessment of Patient Preferences
©2015 MFMER | slide-13
Conclusions
• Blinded clinical grading demonstrated that the
active moisturizing lotion had greater statistical
improvements from baseline compared to the
vehicle for the parameters of scaling, overall
dryness as well as the intensity, duration and
frequency of itch.
• The active moisturizing lotion demonstrated
significantly better hydration as measured by
the Corneometer and SkiCon both at 21 days
and again at 28 days (after the 1 week
regression).
©2015 MFMER | slide-14
Conclusions
• The patient self-assessments also
demonstrated that patients favored the active
moisturizing lotion on almost all tested
attributes.
• There is value in having clear evidence-based
results available for a dermatologist showing
the active ingredients in a skin care product
have the actual effect promised and are more
effective than vehicle.
©2015 MFMER | slide-15
References
1. Moses S. Pruritus. Am Fam Physician. 2003; 68(6):1135-42.
2. Berger TG, Shive M, Harper GM. Pruritus in the older patient: a
clinical review. JAMA 2013;310(22):2443-50.
3. Kurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and
clinical properties. J Drugs Dermatol 2007;6:167-70.
4. Eichenfield LF, Flwler JF Jr, Rigel DS, Taylor SC. Natural advances
in eczema care. Cutis 2007;80:2-16.
5. Draelos ZD. Modern moisturizer myths, misconceptions, and
truths. Cutis 2013;91:308-14.
©2015 MFMER | slide-16