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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis

Conditions
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Eczema, Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Atopic Dermatitis, Compromised Skin, Inflamed Skin