Effect of Different Skin Creams on TEWL

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663673
• Other study ID #: SNP 47028
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

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