Effect of Different Skin Creams on TEWL | NCT03663673

Studies
Effect of Different Skin Creams on TEWL

NCT03663673

Sponsor

Stanford University

Status

Completed

Last Update Posted

Sep 8, 2021Actual

Enrollment

17Actual

Phase

Phase 1

Conditions

Dermatitis, Atopic

Interventions

EpiCeram
Aveeno Daily Moisturising Sheer Hydration Lotion®

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Jul 18, 2019Actual

Completion Date

Jul 18, 2019Actual

First Submitted Date

Sep 6, 2018

First Submission Date that Met QC Criteria

Sep 6, 2018

First Posted Date

Sep 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 8, 2021Actual

Name	Class
End Allergies Together (EAT)	UNKNOWN

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sayantani Sindher, M.D.	Stanford Health Care	Principal Investigator
Kari Nadeau, M.D., PhD	Stanford Health Care	Study Chair

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases

ID	Term
D003876	Dermatitis, Atopic
D003872	Dermatitis