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

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.

Study Overview

• Status: Completed
• Conditions: Eczema; Atopic Dermatitis

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Department of Dermatology
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Medical School - Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients with Atopic Dermatitis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: TopMD Skin Care, Inc.
• Investigators: Principal Investigator: Adelaide A. Hebert, MD, University of Texas Medical School - Houston

Publications and helpful links

General Publications

• 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. Pediatr Dermatol. 2019 Jul;36(4):442-447. doi: 10.1111/pde.13842. Epub 2019 Apr 15.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (ESTIMATE): October 25, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Eczema; Compromised Skin; Inflamed Skin
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CLN 003.6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED