Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-08-31

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.

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Detailed Description

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Conditions

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Moderate to Severe Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Dilute bleach baths

Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.

Group Type ACTIVE_COMPARATOR

Dilute bleach baths

Intervention Type OTHER

Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.

Water

Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.

Interventions

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Dilute bleach baths

Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.

Intervention Type OTHER

Water

Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.

Intervention Type OTHER

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No