NCT01826630

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

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Shari L Hand · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eczema
• Hand Eczema
• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	CLn BodyWash	Comparing two washes to determine change in bacterial load.
OTHER	Cetaphil Daily Facial Cleanser	Comparing two washes to determine change in bacterial load.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-04-08
• Last updated: 2019-09-25

Locations

1 site across 1 country: United States