Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

The University of Texas System (UT)

Status: Terminated

Conditions: Moderate to Severe Atopic Dermatitis

Treatments: Other: Water; Other: Dilute bleach baths

Study type: Interventional

Funder types: Other

Identifiers

NCT01286220

STU 012010-059

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Dilute bleach baths

Active Comparator group

Description:

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

Treatment:

Other: Dilute bleach baths

Water

Placebo Comparator group

Description:

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

Treatment:

Other: Water