Back to resultsDilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
Primary Purpose
Moderate to Severe Atopic Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dilute bleach baths
Water
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Atopic Dermatitis
Eligibility 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.
Sites / Locations
- Children's Medical Center of Dallas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dilute bleach baths
Water
Arm Description
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
Outcomes
Primary Outcome Measures
Eczema Area and Severity Index Score (EASI)
EASI score is recorded at baseline, 1 month and 3 month follow ups.
Secondary Outcome Measures
Investigator's Global Assessment (IGA)
IGA scores are recorded at baseline, 1 month and 3 month follow ups.
Full Information
NCT ID
NCT01286220
First Posted
January 26, 2011
Last Updated
March 18, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Children's Medical Center Dallas
1. Study Identification
Unique Protocol Identification Number
NCT01286220
Brief Title
Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
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 Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
the study was terminated due to participant drop out
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Children's Medical Center Dallas
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dilute bleach baths
Arm Type
Active Comparator
Arm Description
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
Intervention Type
Other
Intervention Name(s)
Dilute bleach baths
Intervention Description
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index Score (EASI)
Description
EASI score is recorded at baseline, 1 month and 3 month follow ups.
Time Frame
Change in EASI score from baseline at 1 month and 3 month follow ups
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA)
Description
IGA scores are recorded at baseline, 1 month and 3 month follow ups.
Time Frame
Change in IGA score from baseline at 1 month and 3month follow ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19403473
Citation
Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
Results Reference
result
Learn more about this trial
Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
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