Effect of Different Skin Creams on TEWL

Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.

Primary Objective: To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no emollient use for one week.

Secondary Objectives: To assess lipid and protein profiles of skin tape strips from non-lesional skin, after a week of either EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no treatment.

Exploratory Objectives :

• To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours after cessation of therapy.
• To evaluate whether baseline food and environmental allergy sensitization (assessed via skin prick testing during screening) affects the outcomes. See protocol section 3.1 for allergen details.
• A central repository of blood samples will be stored for future use to assess plasma biomarkers to help characterize clinical outcome data.

Inclusion criteria

• Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
• Male or female participants, between the ages of 0 to 40 years will be included
• Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score > 26) without a history or current manifestations of eczema herpeticum (EH)
• AD affecting at least 3 different skin areas (contralateral arms and one lower extremity)

Exclusion criteria

• Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
• Participants with skin disease other than AD that might compromise the stratum corneum barriers (e.g., bullous diseases, psoriasis, cutaneous T-cell lymphoma (also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
• Known or suspected immunosuppression
• Severe concomitant illness(es)
• History of serious life-threatening reaction to latex, tape, or adhesives
• Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days of the Enrollment Visit
• Use of topical corticosteroids, topical immunomodulatory agents (such as calcineural inhibitors and crisaborole), or topical antibiotics on the upper or lower extremities within 7 days of the Enrollment Visit
• Has taken a bleach bath within 7 days of the Enrollment Visit
• Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.