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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03663673
Other study ID # SNP 47028
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 1, 2018
Est. completion date July 18, 2019

Study information

Verified date August 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 18, 2019
Est. primary completion date July 18, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Sean N Parker Center For Allergy and Asthma Research Mountain View California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University End Allergies Together (EAT)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin barrier function Skin barrier function, assessed by TEWL 2 weeks
Secondary Baseline food and environmental allergy sensitization Skin prick testing 2 weeks
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