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NCT01826630 Clinical Trial

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

Atopic Dermatitis Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01826630
Other study ID # CLN 2012H0327
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date October 2014

Study information
Verified date November 2014
Source TopMD Skin Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• CLn BodyWash
Comparing two washes to determine change in bacterial load.
• Cetaphil Daily Facial Cleanser
Comparing two washes to determine change in bacterial load.

Locations
Country Name City State
United States Ohio State University Gahanna Ohio

Sponsors (2)
Lead Sponsor Collaborator
Shari L Hand TopMD Skin Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Amount of Skin Fauna Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser. one wash
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