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

September 23, 2019 updated by: Shari L Hand

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Gahanna, Ohio, United States, 43230
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CLn BodyWash
CLn BodyWash will be used to wash hands of patients with Hand Atopic Dermatitis
Other: CLn BodyWash
Comparing two washes to determine change in bacterial load.
ACTIVE_COMPARATOR: Cetaphil Daily Facial Cleanser
Cetaphil Daily Facial Cleanser will be used to wash hands of patients with Hand Atopic Dermatitis
Other: Cetaphil Daily Facial Cleanser
Comparing two washes to determine change in bacterial load.
Other Names:
  • Cetaphil Daily Facial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one wash

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shari L Hand

Collaborators

TopMD Skin Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (ESTIMATE)

April 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 2012H0327

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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