Effect of Different Skin Creams on TEWL

NCT03663673 | Completed Phase 1 FDA Drug

• 1 other identifier: SNP 47028
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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®.

Conditions

Dermatitis, Atopic

Keywords

Dermatitis; emollient; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Skin barrier function

  Skin barrier function, assessed by TEWL

  2 weeks

Secondary Outcomes (1)

• Baseline food and environmental allergy sensitization

  2 weeks

Study Arms (1)

Clinical pilot study

OTHER

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; Drug: Aveeno Daily Moisturising Sheer Hydration Lotion®

Interventions

EpiCeram DRUG

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.

Clinical pilot study

Aveeno Daily Moisturising Sheer Hydration Lotion® DRUG

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.

Clinical pilot study

Eligibility Criteria

• Age: 1 Day - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• End Allergies Together (EAT): collaborator

Study Sites (1)

Sean N Parker Center For Allergy and Asthma Research

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Interventions

EpiCeram

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sayantani Sindher, M.D.

  Stanford Health Care

  PRINCIPAL INVESTIGATOR

• Kari Nadeau, M.D., PhD

  Stanford Health Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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 Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: September 1, 2018
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)