Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

Not Applicable

Terminated

• Conditions: Moderate to Severe Atopic Dermatitis
• Interventions: Other: Dilute bleach baths; Other: Water

• 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

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Primary Completion: 2013-08
• Study Completion: 2017-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

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

Arm && Interventions

Group	Intervention	Description
Dilute bleach baths	Dilute bleach baths	Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
Water	Water	Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.

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.

Trial Locations

Locations (1)

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States