Evaluating the Effects of Cleansers on the Skin

June 1, 2021 updated by: University of Arizona
This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their upper extremities. One spot will serve as a control and not receive any cleanser. Each spot will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes after rinse off.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Up to 50 subjects (up to 25 with healthy skin or 25 with atopic dermatitis) meeting the inclusion criteria will be enrolled in this study. A physical exam will be performed to ensure the subjects have healthy skin versus atopic dermatitis. For atopic dermatitis subjects, AD severity will be graded by the EASI score. Site randomization will be performed to determine which cleansers will be used for each of the 8 test sites (one site will be randomized to act as a control and not receive any cleanser). Baseline skin barrier function (TEWL, pH and hydration) will be measured. Then 1ml of each cleansers will be applied to the corresponding test sites, 2ml of tap water will be added, and lathered in a circular motion for 15 seconds. The sites will then be rinsed off with tap water for 15 seconds. Arms will be padded dry. Barrier functions will be measured again immediately after padding dry, and at 30, 60 and 90 minutes after.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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
    • Arizona
      • Tucson, Arizona, United States, 85718
        • University of Arizona - Banner University Medicine Dermatology

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male and female, at least 18 years of age Subject must be able to comprehend and read the English language. Healthy skin without concurrent atopic dermatitis or diagnosed with atopic dermatitis by a dermatologist

Exclusion Criteria:

Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply with the study procedures Concurrently have other inflammatory skin conditions. Prior known allergy to any components to of the cleansers tested A subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures.

Subject unable to speak or read the English language, since all consents and instructions will be provided in English.

Those that are prisoners or cognitively impaired

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CeraVe® Eczema Soothing Body Wash
One of the 7 forearm locations will be selected to receive CeraVe® Eczema Soothing Body Wash one time only.
Other: CeraVe® Eczema Soothing Body Wash
One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash
Active Comparator: Cetaphil® RestoraDerm® Eczema Calming Body Wash
One of the 7 forearm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash one time only.
Other: Cetaphil® RestoraDerm® Eczema Calming Body Wash
One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash
Active Comparator: Dove® Sensitive Skin Body Wash
One of the 7 forearm locations will be selected to receive Dove® Sensitive Skin Body Wash one time only.
Other: Dove® Sensitive Skin Body Wash
One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash
Active Comparator: Eucerin® Skin Calming Body Wash
One of the 7 forearm locations will be selected to receive Eucerin® Skin Calming Body Wash one time only.
Other: Eucerin® Skin Calming Body Wash
One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash
Active Comparator: Aveeno® Skin Relief Body Wash
One of the 7 forearm locations will be selected to receive Aveeno® Skin Relief Body Wash one time only.
Other: Aveeno® Skin Relief Body Wash
One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash
Active Comparator: MooGoo® Milk Wash
One of the 7 forearm locations will be selected to receive MooGoo® Milk Wash one time only.
Other: MooGoo® Milk Wash
One of the 7 arm locations will be selected to receive MooGoo® Milk Wash
Active Comparator: Free & Clear Liquid Cleanser
One of the 7 forearm locations will be selected to receive Free & Clear Liquid Cleanser
Other: Free & Clear Liquid Cleanser
One of the 7 arm locations will be selected to receive Free & Clear Liquid Cleanser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin barrier function
Time Frame: 2 hours
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter).
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin barrier function
Time Frame: 2 hours
Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC).
2 hours
Skin pH
Time Frame: 2 hours
Skin pH will be measured.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

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)

May 31, 2017

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1705435580

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

No

Studies a U.S. FDA-regulated device product

No

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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