Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis

The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair
Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate
atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these
products. A significant difference exists in the cost of these products; therefore, if our
hypothesis is proved correct - that Aquaphor will be just as efficacious as the more
expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the
overall cost of treating atopic dermatitis.

This is a single center, investigator blinded, randomized, prospective controlled study of
subjects with mild to moderate atopic dermatitis. The study is intended to compare the
efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin
Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All
subjects will receive active study medication and will return to study center for efficacy
and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order
to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to
receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables.
Efficacy will be measured through Investigator's Global Assessment, BSA involvement,
Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt
Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of
Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be
calculated as cost in dollars for change in outcome according to EASI, BSA and VAS.

Inclusion Criteria:

- Male or female with mild to moderate atopic dermatitis, 2-17 years of age, that agree
to participate and provide written consent (and assent if applicable)

- Have an investigator Global Assessment of mild to moderate atopic dermatitis (IGA
rating of 2-3 in the Investigator Global Assessment)

- Percentage of overall body surface area of involvement (BSA) must be > 1% and may
include facial and intertriginous skin.

Exclusion Criteria:

- Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may
influence study outcome, such as systemic corticosteroids.

- Application or use within 2 weeks of baseline of topical corticosteroid medications or
topical anti-inflammatory medication, which may influence study outcome.

- Presence of a concurrent medical condition, which is determined by the investigator to
potentially interfere with study outcomes or patient assessments.

- Introduction of any other prescription medication, topical or systemic, for atopic
dermatitis while participating int he study (oral antihistamines will be allowed, so
long as they are neither initiated nor discontinued during the course of this study)

- Amount of disease involvement that would require >60gm of cream in a 1 week period

- Subjects with known allergy or sensitivity to Aquaphor Healing Ointment, Atopiclair or
EpiCeram or components therein.