Evaluating the Effects of Cleansers on the Skin

NCT ID: NCT03188653

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2020-05-31

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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CeraVe® Eczema Soothing Body Wash

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

Group Type ACTIVE_COMPARATOR

CeraVe® Eczema Soothing Body Wash

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Cetaphil® RestoraDerm® Eczema Calming Body Wash

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Dove® Sensitive Skin Body Wash

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Eucerin® Skin Calming Body Wash

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Aveeno® Skin Relief Body Wash

Intervention Type OTHER

One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash

MooGoo® Milk Wash

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

Group Type ACTIVE_COMPARATOR

MooGoo® Milk Wash

Intervention Type OTHER

One of the 7 arm locations will be selected to receive MooGoo® Milk Wash

Free & Clear Liquid Cleanser

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

Group Type ACTIVE_COMPARATOR

Free & Clear Liquid Cleanser

Intervention Type OTHER

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

Interventions

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Aveeno® Skin Relief Body Wash

One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash

Intervention Type OTHER

MooGoo® Milk Wash

One of the 7 arm locations will be selected to receive MooGoo® Milk Wash

Intervention Type OTHER

Free & Clear Liquid Cleanser

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

Intervention Type OTHER

CeraVe® Eczema Soothing Body Wash

One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash

Intervention Type OTHER

Cetaphil® RestoraDerm® Eczema Calming Body Wash

One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash

Intervention Type OTHER

Dove® Sensitive Skin Body Wash

One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash

Intervention Type OTHER

Eucerin® Skin Calming Body Wash

One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash

Intervention Type OTHER

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


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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1705435580

Identifier Type: -

Identifier Source: org_study_id

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