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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin barrier function
Time Frame: 2 weeks
Skin barrier function, assessed by TEWL
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
End Allergies Together (EAT)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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