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

Not Applicable

Terminated

• Conditions: Eczema; Atopic Dermatitis; Hand Eczema
• Interventions: Other: CLn BodyWash; Other: Cetaphil Daily Facial Cleanser

• Registration Number: NCT01826630
• Lead Sponsor: Shari L Hand

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Study Start: 2013-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLn BodyWash	CLn BodyWash	CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
Cetaphil Daily Facial Cleanser	Cetaphil Daily Facial Cleanser	Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis

Primary Outcome Measures

Name	Time	Method
Change in Amount of Skin Fauna	one wash	Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Gahanna, Ohio, United States