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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Change in Amount of Skin Fauna
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CLn BodyWash
CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
Intervention: CLn BodyWash (Other)
Cetaphil Daily Facial Cleanser
Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis
Intervention: Cetaphil Daily Facial Cleanser (Other)
Outcomes
Primary Outcomes
Change in Amount of Skin Fauna
Time Frame: one wash
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
Secondary Outcomes
No secondary outcomes reported
Investigators
Shari L Hand
Clinical Research Director
TopMD Skin Care, Inc.