Moderate to Severe Atopic Dermatitis
Conditions
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.
Interventions
OTHERDilute bleach baths
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
OTHERWater
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
Sponsors
Children's Medical Center Dallas
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed