Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
Not Applicable
Terminated
- Conditions
- Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT01286220
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths decreases disease severity in patients with moderate to severe atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- 2-17 years of age at time of consent. A parent or legal guardian will be required to consent and authorize their enrollment in the study.
- Male or female of any ethnic background.
- English or Spanish speaking.
- A clinical diagnosis of atopic dermatitis for at least 6 months prior to enrollment.
- Must have moderate to severe atopic dermatitis as rated by the EASI score.
- Able to adhere to study visit schedule and other protocol requirements.
- Patients and/or family members must agree to not use any other prescription or over the counter medications other than the ones prescribed by the study protocol.
Exclusion Criteria
- Clinical evidence of bacterial or viral superinfection on first visit.
- Have received phototherapy within 2 months prior to enrollment.
- Have received any systemic medication for atopic dermatitis or any that may affect evaluation of atopic dermatitis within 2 months prior to enrollment.
- Have a known hypersensitivity response, including anaphylaxis, to any of the topicals used for treatment (i.e. topical steroids, bleach)
- Participation in another clinical trial using an investigational agent or procedure.
- Pregnant or planning pregnancy or surgery during the participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Eczema Area and Severity Index Score (EASI) Change in EASI score from baseline at 1 month and 3 month follow ups EASI score is recorded at baseline, 1 month and 3 month follow ups.
- Secondary Outcome Measures
Name Time Method Investigator's Global Assessment (IGA) Change in IGA score from baseline at 1 month and 3month follow ups IGA scores are recorded at baseline, 1 month and 3 month follow ups.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of dilute bleach baths in reducing atopic dermatitis severity in pediatric patients?
How do dilute bleach baths compare to standard-of-care topical corticosteroids in managing moderate to severe atopic dermatitis in children?
Are there specific biomarkers, such as Th2 cytokines or filaggrin mutations, that predict response to dilute bleach baths in atopic dermatitis?
What adverse events were reported in NCT01286220 and how do they align with bleach-based interventions in pediatric dermatology?
What combination therapies or alternative antimicrobial agents show synergistic effects with dilute bleach baths for atopic dermatitis treatment?
Trial Locations
- Locations (1)
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Children's Medical Center of Dallas🇺🇸Dallas, Texas, United States