Dermatitis, Atopic Clinical Trial
Official title:
Comparison of Two Different Skin Creams and Their Effect on Transepidermal Water Loss (TEWL) in Pediatric and Adult Patients With Atopic Dermatitis: A Pilot Study
Verified date | August 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Sean N Parker Center For Allergy and Asthma Research | Mountain View | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | End Allergies Together (EAT) |
United States,
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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