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

October 18, 2012
July 10, 2014
November 2012
December 2013   (final data collection date for primary outcome measure)
  • 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.
Improvement in Health of Skin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Decrease from baseline in Eczema Area Severity Index (EASI) Score, Investigator Global Assessment (IGA) Score, and/or Body Surface Area (BSA) Score.
Complete list of historical versions of study NCT01714245 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients
A Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Pediatric patients with Atopic Dermatitis

  • Eczema
  • Atopic Dermatitis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01714245
CLN 003.6
No
TopMD Skin Care, Inc.
TopMD Skin Care, Inc.
Not Provided
Principal Investigator: Adelaide A. Hebert, MD University of Texas Medical School - Houston
TopMD Skin Care, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP