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Effect of Different Skin Creams on TEWL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663673
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Sayantani B. Sindher, Stanford University

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®.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: EpiCeram Drug: Aveeno Daily Moisturising Sheer Hydration Lotion® Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Skin barrier function [ Time Frame: 2 weeks ]
    Skin barrier function, assessed by TEWL


Secondary Outcome Measures :
  1. Baseline food and environmental allergy sensitization [ Time Frame: 2 weeks ]
    Skin prick testing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663673


Locations
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United States, California
Sean N Parker Center For Allergy and Asthma Research
Mountain View, California, United States, 94040
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sayantani Sindher, M.D. Stanford Health Care
Study Chair: Kari Nadeau, M.D., PhD Stanford Health Care
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Responsible Party: Sayantani B. Sindher, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03663673    
Other Study ID Numbers: SNP 47028
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sayantani B. Sindher, Stanford University:
Dermatitis
emollient
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Decanoic acid
Antifungal Agents
Anti-Infective Agents