Clinical trial NCT01714245: A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eczema
Atopic Dermatitis
Keywords: Eczema
Atopic Dermatitis
Compromised Skin
Inflamed Skin
Lead sponsor: TopMD Skin Care, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with Atopic Dermatitis

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.

Eligibility 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

Primary outcomes:
measure: Improvement in Health of Skin EASI
timeFrame: 6 weeks
measure: Improvement in Health of Skin IGA
timeFrame: 6 weeks
measure: Improvement in Health of Skin BSA
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks
measure: Decreased itching
timeFrame: 6 weeks
measure: Reduction of bacteria
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Department of Dermatology
state: Illinois
city: Houston
country: United States
facility: University of Texas Medical School - Houston
state: Texas
Study officials:
affiliation: University of Texas Medical School - Houston
name: Adelaide A. Hebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.