Effect of Different Skin Creams on TEWL

August 31, 2021 updated by: Sayantani B. Sindher, Stanford University

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Sean N Parker Center For Allergy and Asthma Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 36 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin barrier function
Time Frame: 2 weeks
Skin barrier function, assessed by TEWL
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline food and environmental allergy sensitization
Time Frame: 2 weeks
Skin prick testing
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

July 18, 2019

Study Completion (Actual)

July 18, 2019

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNP 47028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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