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Completed

NCT Number: NCT01714245

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

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.

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University, Department of Dermatology, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Improvement in Health of Skin EASI

    Time frame: 6 weeks

    Change from baseline in Eczema Area Severity Index (EASI) Score.

  2. Improvement in Health of Skin IGA

    Time frame: 6 weeks

    Change from baseline in Investigator Global Assessment (IGA) Score.

  3. Improvement in Health of Skin BSA

    Time frame: 6 weeks

    Change from baseline in Body Surface Area (BSA) Score.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 6 weeks

    Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.

  2. Decreased itching

    Time frame: 6 weeks

    Visual Analog Scale will be reviewed for decrease in pruritus.

  3. Reduction of bacteria

    Time frame: 6 weeks

    Bacterial cultures will be evaluated for decreased quantitative numbers.

Sponsors and collaborators

Lead sponsor

TopMD Skin Care, Inc.

Industry

Registry information

Official study 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

Acronym: CLeaN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2012
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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