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Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Children's Medical Center Dallas
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01286220
First received: January 26, 2011
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

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 Intervention
Moderate to Severe Atopic Dermatitis
Other: Dilute bleach baths
Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Eczema Area and Severity Index Score (EASI) [ Time Frame: Change in EASI score from baseline at 1 month and 3 month follow ups ] [ Designated as safety issue: No ]
    EASI score is recorded at baseline, 1 month and 3 month follow ups.


Secondary Outcome Measures:
  • Investigator's Global Assessment (IGA) [ Time Frame: Change in IGA score from baseline at 1 month and 3month follow ups ] [ Designated as safety issue: No ]
    IGA scores are recorded at baseline, 1 month and 3 month follow ups.


Estimated Enrollment: 40
Study Start Date: December 2010
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286220

Contacts
Contact: Annabelle L Garcia, MD 214-564-2105 algarciamd@gmail.com
Contact: Amit Pandya, MD 214-648-5770 amit.pandya@utsouthwestern.edu

Locations
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Maurica Contreras, NP    214-456-6328    maurica.contreras@childrens.com   
Principal Investigator: Annabelle L Garcia, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
  More Information

Publications:
Responsible Party: Annabelle Garcia, M.D., UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01286220     History of Changes
Other Study ID Numbers: 012010-059
Study First Received: January 26, 2011
Last Updated: January 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 25, 2014