search
Back to results

Effect of Different Skin Creams on TEWL

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EpiCeram
Aveeno Daily Moisturising Sheer Hydration Lotion®
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, emollient, Atopic Dermatitis

Eligibility Criteria

1 Day - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sean N Parker Center For Allergy and Asthma Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical pilot study

Arm Description

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.

Outcomes

Primary Outcome Measures

Skin barrier function
Skin barrier function, assessed by TEWL

Secondary Outcome Measures

Baseline food and environmental allergy sensitization
Skin prick testing

Full Information

First Posted
September 6, 2018
Last Updated
August 31, 2021
Sponsor
Stanford University
Collaborators
End Allergies Together (EAT)
search

1. Study Identification

Unique Protocol Identification Number
NCT03663673
Brief Title
Effect of Different Skin Creams on TEWL
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
End Allergies Together (EAT)

4. Oversight

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
Data Monitoring Committee
No

5. 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®.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dermatitis, emollient, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model 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®.
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical pilot study
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EpiCeram
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aveeno Daily Moisturising Sheer Hydration Lotion®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin barrier function
Description
Skin barrier function, assessed by TEWL
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Baseline food and environmental allergy sensitization
Description
Skin prick testing
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations. Male or female participants, between the ages of 0 to 40 years will be included Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score > 26) 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: Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol. 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). Known or suspected immunosuppression Severe concomitant illness(es) History of serious life-threatening reaction to latex, tape, or adhesives 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 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 Has taken a bleach bath within 7 days of the Enrollment Visit Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayantani Sindher, M.D.
Organizational Affiliation
Stanford Health Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kari Nadeau, M.D., PhD
Organizational Affiliation
Stanford Health Care
Official's Role
Study Chair
Facility Information:
Facility Name
Sean N Parker Center For Allergy and Asthma Research
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Different Skin Creams on TEWL

We'll reach out to this number within 24 hrs