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Evaluating the Effects of Cleansers on the Skin

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CeraVe® Eczema Soothing Body Wash
Cetaphil® RestoraDerm® Eczema Calming Body Wash
Dove® Sensitive Skin Body Wash
Eucerin® Skin Calming Body Wash
Aveeno® Skin Relief Body Wash
MooGoo® Milk Wash
Free & Clear Liquid Cleanser
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arizona - Banner University Medicine Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

CeraVe® Eczema Soothing Body Wash

Cetaphil® RestoraDerm® Eczema Calming Body Wash

Dove® Sensitive Skin Body Wash

Eucerin® Skin Calming Body Wash

Aveeno® Skin Relief Body Wash

MooGoo® Milk Wash

Free & Clear Liquid Cleanser

Arm Description

One of the 7 forearm locations will be selected to receive CeraVe® Eczema Soothing Body Wash one time only.

One of the 7 forearm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash one time only.

One of the 7 forearm locations will be selected to receive Dove® Sensitive Skin Body Wash one time only.

One of the 7 forearm locations will be selected to receive Eucerin® Skin Calming Body Wash one time only.

One of the 7 forearm locations will be selected to receive Aveeno® Skin Relief Body Wash one time only.

One of the 7 forearm locations will be selected to receive MooGoo® Milk Wash one time only.

One of the 7 forearm locations will be selected to receive Free & Clear Liquid Cleanser

Outcomes

Primary Outcome Measures

Skin barrier function
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter).

Secondary Outcome Measures

Skin barrier function
Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC).
Skin pH
Skin pH will be measured.

Full Information

First Posted
May 30, 2017
Last Updated
June 1, 2021
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03188653
Brief Title
Evaluating the Effects of Cleansers on the Skin
Official Title
Evaluating the Effects of Cleansers on the Skin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Investigator left university
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CeraVe® Eczema Soothing Body Wash
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive CeraVe® Eczema Soothing Body Wash one time only.
Arm Title
Cetaphil® RestoraDerm® Eczema Calming Body Wash
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash one time only.
Arm Title
Dove® Sensitive Skin Body Wash
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive Dove® Sensitive Skin Body Wash one time only.
Arm Title
Eucerin® Skin Calming Body Wash
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive Eucerin® Skin Calming Body Wash one time only.
Arm Title
Aveeno® Skin Relief Body Wash
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive Aveeno® Skin Relief Body Wash one time only.
Arm Title
MooGoo® Milk Wash
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive MooGoo® Milk Wash one time only.
Arm Title
Free & Clear Liquid Cleanser
Arm Type
Active Comparator
Arm Description
One of the 7 forearm locations will be selected to receive Free & Clear Liquid Cleanser
Intervention Type
Other
Intervention Name(s)
CeraVe® Eczema Soothing Body Wash
Intervention Description
One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash
Intervention Type
Other
Intervention Name(s)
Cetaphil® RestoraDerm® Eczema Calming Body Wash
Intervention Description
One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash
Intervention Type
Other
Intervention Name(s)
Dove® Sensitive Skin Body Wash
Intervention Description
One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash
Intervention Type
Other
Intervention Name(s)
Eucerin® Skin Calming Body Wash
Intervention Description
One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash
Intervention Type
Other
Intervention Name(s)
Aveeno® Skin Relief Body Wash
Intervention Description
One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash
Intervention Type
Other
Intervention Name(s)
MooGoo® Milk Wash
Intervention Description
One of the 7 arm locations will be selected to receive MooGoo® Milk Wash
Intervention Type
Other
Intervention Name(s)
Free & Clear Liquid Cleanser
Intervention Description
One of the 7 arm locations will be selected to receive Free & Clear Liquid Cleanser
Primary Outcome Measure Information:
Title
Skin barrier function
Description
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Skin barrier function
Description
Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC).
Time Frame
2 hours
Title
Skin pH
Description
Skin pH will be measured.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Arizona - Banner University Medicine Dermatology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating the Effects of Cleansers on the Skin

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