A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema

Study Overview
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Brief Summary
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The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.

Detailed Description
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Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.

Official Title
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A Double-Blind Pilot Study To Assess The Feasibility of a Larger Study to Assess The Efficacy of A Novel Gel Wash Cleanser Formulated With Sodium Hypochlorite To Reduce Skin Fauna In Patients With Chronic Hand Dermatitis/Atopic Dermatitis.

Conditions
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Eczema, Hand Eczema, Atopic Dermatitis

Intervention / Treatment
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* Other: CLn BodyWash
* Other: Cetaphil Daily Facial Cleanser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals Willingness to participate in a research study. Diagnosis of chronic hand dermatitis Exclusion Criteria: Inability to provide informed consent Allergy to any of the treatments used

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLn BodyWash<br>CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis | Other: CLn BodyWash<br>* Comparing two washes to determine change in bacterial load.<br>|
| Active Comparator: Cetaphil Daily Facial Cleanser<br>Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis | Other: Cetaphil Daily Facial Cleanser<br>* Comparing two washes to determine change in bacterial load.<br>* Other names: Cetaphil Daily Facial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Amount of Skin Fauna | Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser. | one wash | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLn Body Wash, CLn BodyWash