Trial record 3 of 48 for:    Open Studies | "Eczema"

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

This study is currently recruiting participants.
Verified July 2013 by TopMD Skin Care, Inc.
Sponsor:
Collaborator:
TopMD Skin Care, Inc.
Information provided by (Responsible Party):
Shari L Hand, TopMD Skin Care, Inc.
ClinicalTrials.gov Identifier:
NCT01826630
First received: February 20, 2013
Last updated: July 13, 2013
Last verified: July 2013
  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 Blind (Subject, 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 TopMD Skin Care, Inc.:

Primary Outcome Measures:
  • Change in Amount of Skin Fauna [ Time Frame: one wash ] [ Designated as safety issue: No ]
    Mean Decrease in Fauna after Washing with either CLn BodyWash or Cetaphil Daily Facial Cleanser.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 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.
Other Name: CLn BodyWash
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826630

Contacts
Contact: Derek V. Chan, MD, PhD 614.293.1707 derek.chan@osumc.edu

Locations
United States, Ohio
Ohio State University Recruiting
Gahanna, Ohio, United States, 43230
Contact: Derek V. Chan, MD, PhD    614-293-1707    derek.chan@osumc.edu   
Principal Investigator: Matthew Zirwas, MD         
Sponsors and Collaborators
Shari L Hand
TopMD Skin Care, Inc.
  More Information

No publications provided

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
Study First Received: February 20, 2013
Last Updated: July 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on April 14, 2014