Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01286220

Collaborator

Children's Medical Center Dallas (Other)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Atopic Dermatitis	Other: Dilute bleach baths Other: Water	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Dilute bleach baths

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

Other: Dilute bleach baths

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

Placebo Comparator: Water

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

Other: Water

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Medical Center of Dallas	Dallas	Texas	United States	75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center
Children's Medical Center Dallas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT01286220

Other Study ID Numbers:

STU 012010-059

First Posted:

Jan 31, 2011

Last Update Posted:

Mar 20, 2020

Last Verified:

Mar 1, 2020

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Eczema

Study Results

No Results Posted as of Mar 20, 2020