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

Completed

• Conditions: Eczema; Atopic Dermatitis

• Registration Number: NCT01714245
• Lead Sponsor: TopMD Skin Care, Inc.

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Health of Skin EASI	6 weeks	Change from baseline in Eczema Area Severity Index (EASI) Score.
Improvement in Health of Skin IGA	6 weeks	Change from baseline in Investigator Global Assessment (IGA) Score.
Improvement in Health of Skin BSA	6 weeks	Change from baseline in Body Surface Area (BSA) Score.

Secondary Outcome Measures

Name	Time	Method
Decreased itching	6 weeks	Visual Analog Scale will be reviewed for decrease in pruritus.
Reduction of bacteria	6 weeks	Bacterial cultures will be evaluated for decreased quantitative numbers.
Patient satisfaction	6 weeks	Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.

Trial Locations

Locations (2)

University of Texas Medical School - Houston; 🇺🇸 Houston, Texas, United States

Northwestern University, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States