Effect of Different Skin Creams on TEWL
Study Details
Study Description
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®.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 :
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To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours after cessation of therapy.
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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.
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A central repository of blood samples will be stored for future use to assess plasma biomarkers to help characterize clinical outcome data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Clinical pilot study 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. |
Drug: 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.
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Skin barrier function [2 weeks]
Skin barrier function, assessed by TEWL
Secondary Outcome Measures
- Baseline food and environmental allergy sensitization [2 weeks]
Skin prick testing
Eligibility Criteria
Criteria
Inclusion Criteria:
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Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
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Male or female participants, between the ages of 0 to 40 years will be included
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Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score >
- 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:
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Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
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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).
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Known or suspected immunosuppression
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Severe concomitant illness(es)
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History of serious life-threatening reaction to latex, tape, or adhesives
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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
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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
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Has taken a bleach bath within 7 days of the Enrollment Visit
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Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sean N Parker Center For Allergy and Asthma Research | Mountain View | California | United States | 94040 |
Sponsors and Collaborators
- Stanford University
- End Allergies Together (EAT)
Investigators
- Principal Investigator: Sayantani Sindher, M.D., Stanford Health Care
- Study Chair: Kari Nadeau, M.D., PhD, Stanford Health Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNP 47028