Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

March 18, 2020 updated by: University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index Score (EASI)
Time Frame: 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.
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)
Time Frame: 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.
Change in IGA score from baseline at 1 month and 3month follow ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Children's Medical Center Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 012010-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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