Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01714245
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2012-10-18
Brief Title:
A Study to Evaluate CLn BodyWash As Added Therapy in Eczema Patients
Sponsor:
TopMD Skin Care Inc
Organization:
TopMD Skin Care Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLeaN
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 0009 sodium hypochlorite concentration wwwbleachbathcom CLn BodyWash contains several common surfactants to clean the skin and 0006 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
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 0009 sodium hypochlorite concentration wwwbleachbathcom CLn BodyWash contains several common surfactants to clean the skin and 0006 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None