Effect of Different Skin Creams on TEWL

Phase 1

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: EpiCeram; Drug: Aveeno Daily Moisturising Sheer Hydration Lotion®

• Registration Number: NCT03663673
• Lead Sponsor: Stanford University

Brief Summary

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®.

Detailed 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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Primary Completion: 2019-07-18
• Study Completion: 2019-07-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical pilot study	EpiCeram	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.
Clinical pilot study	Aveeno Daily Moisturising Sheer Hydration Lotion®	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.

Primary Outcome Measures

Name	Time	Method
Skin barrier function	2 weeks	Skin barrier function, assessed by TEWL

Secondary Outcome Measures

Name	Time	Method
Baseline food and environmental allergy sensitization	2 weeks	Skin prick testing

Trial Locations

Locations (1)

Sean N Parker Center For Allergy and Asthma Research; 🇺🇸 Mountain View, California, United States