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

Atopic Dermatitis Clinical Trial

— CLeaN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714245
• Other study ID #: CLN 003.6
• Status: Completed
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2019
• Source: TopMD Skin Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
United States	Northwestern University, Department of Dermatology	Chicago	Illinois
United States	University of Texas Medical School - Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
TopMD Skin Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Majewski S, Bhattacharya T, Asztalos M, Bohaty B, Durham KC, West DP, Hebert AA, Paller AS. Sodium hypochlorite body wash in the management of Staphylococcus aureus-colonized moderate-to-severe atopic dermatitis in infants, children, and adolescents. Pedi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Health of Skin EASI	Change from baseline in Eczema Area Severity Index (EASI) Score.	6 weeks
Primary	Improvement in Health of Skin IGA	Change from baseline in Investigator Global Assessment (IGA) Score.	6 weeks
Primary	Improvement in Health of Skin BSA	Change from baseline in Body Surface Area (BSA) Score.	6 weeks
Secondary	Patient satisfaction	Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.	6 weeks
Secondary	Decreased itching	Visual Analog Scale will be reviewed for decrease in pruritus.	6 weeks
Secondary	Reduction of bacteria	Bacterial cultures will be evaluated for decreased quantitative numbers.	6 weeks