Evaluating the Effects of Cleansers on the Skin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Effects of Cleansers on the Skin

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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