Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled, Evaluator-blinded Study to Evaluate the Efficacy of Dilute Bleach Baths on Skin Disease Control in Pediatric Patients With Atopic Dermatitis

Conditions
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Moderate to Severe Atopic Dermatitis

Intervention / Treatment
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* Other: Dilute bleach baths
* Other: Water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dilute bleach baths<br>Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes. | Other: Dilute bleach baths<br>* Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.<br>|
| Placebo Comparator: Water<br>Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes. | Other: Water<br>* Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index Score (EASI) | EASI score is recorded at baseline, 1 month and 3 month follow ups. | Change in EASI score from baseline at 1 month and 3 month follow ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) | IGA scores are recorded at baseline, 1 month and 3 month follow ups. | Change in IGA score from baseline at 1 month and 3month follow ups |