A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients (CLeaN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TopMD Skin Care, Inc.
ClinicalTrials.gov Identifier:
NCT01714245
First received: October 18, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser formulated with surfactants and preserved with sodium hypochlorite, is effective at decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or eczema.


Condition
Eczema
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement in Health of Skin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Eczema Area Severity Index (EASI) Score.

  • Improvement in Health of Skin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Investigator Global Assessment (IGA) Score.

  • Improvement in Health of Skin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Body Surface Area (BSA) Score.


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.

  • Decreased itching [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Visual Analog Scale will be reviewed for decrease in pruritus.

  • Reduction of bacteria [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Bacterial cultures will be evaluated for decreased quantitative numbers.


Enrollment: 50
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Staphylococcus aureus colonization and potential infection represent a common clinical finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the disease. Atopic patients are commonly colonized with S. aureus on both lesional and non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the bacterial infection as well as reduce the overall severity of AD. More recently, measures to reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.

Given the increasing incidence of recurrent skin infections caused by S. aureus, measures such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an effort to decrease infection rates and disease severity in patients with atopic dermatitis, recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in patients without active clinical infection as one review noted limited benefit while another study showed that dilute bleach baths improved AD.

Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation, and is further diluted when lathered onto the skin with water. This over the counter product is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower, lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a convenient alternative to bleach baths.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pediatric patients with Atopic Dermatitis

Criteria

Inclusion Criteria:

  • 6 months to 18 years
  • moderate to severe Atopic Dermatitis
  • positive staphylococcus aureus skin culture

Exclusion Criteria:

  • active clinical infection
  • on antibiotics in the last 4 weeks
  • on immunosuppression drug in the last 4 weeks
  • using bleach bath in the last 2 weeks
  • able to maintain current regimen
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714245

Locations
United States, Illinois
Northwestern University, Department of Dermatology
Chicago, Illinois, United States, 60611
United States, Texas
University of Texas Medical School - Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
TopMD Skin Care, Inc.
Investigators
Principal Investigator: Adelaide A. Hebert, MD University of Texas Medical School - Houston
  More Information

No publications provided

Responsible Party: TopMD Skin Care, Inc.
ClinicalTrials.gov Identifier: NCT01714245     History of Changes
Other Study ID Numbers: CLN 003.6
Study First Received: October 18, 2012
Last Updated: July 10, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by TopMD Skin Care, Inc.:
Eczema
Atopic Dermatitis
Compromised Skin
Inflamed Skin

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 July 26, 2014