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NCT03188653 Clinical Trial

Evaluating the Effects of Cleansers on the Skin

Atopic Dermatitis Clinical Trial

Official title:
Evaluating the Effects of Cleansers on the Skin

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03188653
Other study ID # 1705435580
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 31, 2017
Est. completion date May 31, 2020

Study information
Verified date June 2021
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• CeraVe® Eczema Soothing Body Wash
One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash
• Cetaphil® RestoraDerm® Eczema Calming Body Wash
One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash
• Dove® Sensitive Skin Body Wash
One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash
• Eucerin® Skin Calming Body Wash
One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash
• Aveeno® Skin Relief Body Wash
One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash
• MooGoo® Milk Wash
One of the 7 arm locations will be selected to receive MooGoo® Milk Wash
• Free & Clear Liquid Cleanser
One of the 7 arm locations will be selected to receive Free & Clear Liquid Cleanser

Locations
Country Name City State
United States University of Arizona - Banner University Medicine Dermatology Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin barrier function Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter). 2 hours
Secondary Skin barrier function Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC). 2 hours
Secondary Skin pH Skin pH will be measured. 2 hours
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