Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis

This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic
dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus)
cream 1% and Hylatopicâ„¢ Plus Emollient Foamâ„¢ in subjects with atopic dermatitis. Subjects
will apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target
eczematous area located on one side of the body and then apply Hylatopicâ„¢ Plus Emollient
Foamâ„¢ three times daily on a symmetrical target eczematous area on the opposite side of the
body. A randomized list will be created to determine which side the subject applies each
medication.

Subjects will be consented prior to any study evaluations or procedures. After signing the
consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will
apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected
areas for four weeks. Photography will be used to record the location of target lesions at
the baseline, week two and week four/final visits. Subject's disease status will be
assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom
Score (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline
(Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for
each of the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or
absence of skin atrophy and telangiectasias will be noted at each study visit as well.

Additionally, subjects' self-assessments of their perception of degree of disease and
itching severity control will be collected at each visit for each target lesion. This
assessment will be made using a four point scale and Itch Severity Scale (visual analogue
score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference
Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate
Product Preference Surveys for subjects that are younger than 12 years of age.