Effect of Different Skin Creams on TEWL

Stanford University

Status and phase: Completed; Phase 1

Conditions: Dermatitis, Atopic

Treatments: Drug: Aveeno Daily Moisturising Sheer Hydration Lotion®; Drug: EpiCeram

Study type: Interventional

Funder types: Other

Identifiers

NCT03663673

SNP 47028

Details and patient eligibility

About

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®.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 1 day to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
2. 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).
3. Known or suspected immunosuppression
4. Severe concomitant illness(es)
5. History of serious life-threatening reaction to latex, tape, or adhesives
6. 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
7. 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
8. Has taken a bleach bath within 7 days of the Enrollment Visit
9. Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Clinical pilot study

Other group

Description:

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®, and no emollient use over a period of one week.

Treatment:

Drug: EpiCeram

Drug: Aveeno Daily Moisturising Sheer Hydration Lotion®