A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients
CLeaN
A Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis
1 other identifier
observational
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 25, 2019
September 1, 2019
1.1 years
October 18, 2012
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Patient satisfaction
6 weeks
Decreased itching
6 weeks
Reduction of bacteria
6 weeks
Eligibility Criteria
Pediatric patients with Atopic Dermatitis
You may qualify if:
- months to 18 years
- moderate to severe Atopic Dermatitis
- positive staphylococcus aureus skin culture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University, Department of Dermatology
Chicago, Illinois, 60611, United States
University of Texas Medical School - Houston
Houston, Texas, 77030, United States
Related Publications (1)
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. Pediatr Dermatol. 2019 Jul;36(4):442-447. doi: 10.1111/pde.13842. Epub 2019 Apr 15.
PMID: 30983053RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adelaide A. Hebert, MD
University of Texas Medical School - Houston
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2012
First Posted
October 25, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 25, 2019
Record last verified: 2019-09