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

This study has been terminated.
(Difficulty enrolling patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01826630
First Posted: April 8, 2013
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TopMD Skin Care, Inc.
Information provided by (Responsible Party):
Shari L Hand, TopMD Skin Care, Inc.
  Purpose
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.

Condition Intervention Phase
Eczema Hand Eczema Atopic Dermatitis Other: CLn BodyWash Other: Cetaphil Daily Facial Cleanser Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


Further study details as provided by Shari L Hand, TopMD Skin Care, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 4
Study Start Date: July 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cetaphil Daily Facial

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826630


Locations
United States, Ohio
Ohio State University
Gahanna, Ohio, United States, 43230
Sponsors and Collaborators
Shari L Hand
TopMD Skin Care, Inc.
  More Information

Responsible Party: Shari L Hand, Clinical Research Director, TopMD Skin Care, Inc.
ClinicalTrials.gov Identifier: NCT01826630     History of Changes
Other Study ID Numbers: CLN 2012H0327
First Submitted: February 20, 2013
First Posted: April 8, 2013
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Shari L Hand, TopMD Skin Care, Inc.:
CLn Body Wash
CLn BodyWash

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases