Study Stopped
Difficulty enrolling patients
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.
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 25, 2019
November 1, 2014
1.3 years
February 20, 2013
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Amount of Skin Fauna
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
one wash
Study Arms (2)
CLn BodyWash
ACTIVE COMPARATORCLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
Cetaphil Daily Facial Cleanser
ACTIVE COMPARATORCetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis
Interventions
Comparing two washes to determine change in bacterial load.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to provide informed consent
- Allergy to any of the treatments used
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shari L Handlead
- TopMD Skin Care, Inc.collaborator
Study Sites (1)
Ohio State University
Gahanna, Ohio, 43230, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Research Director
Study Record Dates
First Submitted
February 20, 2013
First Posted
April 8, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 25, 2019
Record last verified: 2014-11