A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema
Primary Purpose
Eczema, Hand Eczema, Atopic Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLn BodyWash
Cetaphil Daily Facial Cleanser
Sponsored by
About this trial
This is an interventional basic science trial for Eczema focused on measuring CLn Body Wash, CLn BodyWash
Eligibility Criteria
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
Sites / Locations
- Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CLn BodyWash
Cetaphil Daily Facial Cleanser
Arm Description
CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis
Outcomes
Primary Outcome Measures
Change in Amount of Skin Fauna
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
Secondary Outcome Measures
Full Information
NCT ID
NCT01826630
First Posted
February 20, 2013
Last Updated
September 23, 2019
Sponsor
Shari L Hand
Collaborators
TopMD Skin Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01826630
Brief Title
A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Difficulty enrolling patients
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shari L Hand
Collaborators
TopMD Skin Care, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Hand Eczema, Atopic Dermatitis
Keywords
CLn Body Wash, CLn BodyWash
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLn BodyWash
Arm Type
Active Comparator
Arm Description
CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
Arm Title
Cetaphil Daily Facial Cleanser
Arm Type
Active Comparator
Arm Description
Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis
Intervention Type
Other
Intervention Name(s)
CLn BodyWash
Intervention Description
Comparing two washes to determine change in bacterial load.
Intervention Type
Other
Intervention Name(s)
Cetaphil Daily Facial Cleanser
Other Intervention Name(s)
Cetaphil Daily Facial
Intervention Description
Comparing two washes to determine change in bacterial load.
Primary Outcome Measure Information:
Title
Change in Amount of Skin Fauna
Description
Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.
Time Frame
one wash
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ohio State University
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema
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