A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Skin and Soft Tissue Infections, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 5/5/2014 |
| Start Date: | November 2012 |
| End Date: | December 2013 |
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.
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.
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.
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.
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
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