Atopic Dermatitis Clinical Trial
— CLeaNOfficial 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
NCT number | NCT01714245 |
Other study ID # | CLN 003.6 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | December 2013 |
Verified date | September 2019 |
Source | TopMD Skin Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University, Department of Dermatology | Chicago | Illinois |
United States | University of Texas Medical School - Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
TopMD Skin Care, Inc. |
United States,
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. Pedi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Health of Skin EASI | Change from baseline in Eczema Area Severity Index (EASI) Score. | 6 weeks | |
Primary | Improvement in Health of Skin IGA | Change from baseline in Investigator Global Assessment (IGA) Score. | 6 weeks | |
Primary | Improvement in Health of Skin BSA | Change from baseline in Body Surface Area (BSA) Score. | 6 weeks | |
Secondary | Patient satisfaction | Quality of Life Questionnaires will be reviewed for a patient and family satisfaction. | 6 weeks | |
Secondary | Decreased itching | Visual Analog Scale will be reviewed for decrease in pruritus. | 6 weeks | |
Secondary | Reduction of bacteria | Bacterial cultures will be evaluated for decreased quantitative numbers. | 6 weeks |
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