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Evaluating the Effects of Cleansers on the Skin

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ClinicalTrials.gov Identifier: NCT03188653
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Brief 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: CeraVe® Eczema Soothing Body Wash Other: Cetaphil® RestoraDerm® Eczema Calming Body Wash Other: Dove® Sensitive Skin Body Wash Other: Eucerin® Skin Calming Body Wash Other: Aveeno® Skin Relief Body Wash Other: MooGoo® Milk Wash Other: Free & Clear Liquid Cleanser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effects of Cleansers on the Skin
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Skin barrier function [ Time Frame: 2 hours ]
    Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC).

  2. Skin pH [ Time Frame: 2 hours ]
    Skin pH will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188653


Contacts
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Contact: UA Dermatology Clinical Trials Unit 520-694-1828 uadermatologyresearch@gmail.com

Locations
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United States, Arizona
University of Arizona - Banner University Medicine Dermatology Recruiting
Tucson, Arizona, United States, 85718
Contact: UA Dermatology Clinical Trials Unit    520-694-1828    uadermatologyresearch@gmail.com   
Principal Investigator: Vivian Y Shi, MD         
Sponsors and Collaborators
University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03188653    
Other Study ID Numbers: 1705435580
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases