Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

NCT01286220 | Terminated

• 1 other identifier: STU 012010-059
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity Index Score (EASI)

  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 Outcomes (1)

• Investigator's Global Assessment (IGA)

  Change in IGA score from baseline at 1 month and 3month follow ups

Study Arms (2)

Dilute bleach baths

ACTIVE COMPARATOR

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

Other: Dilute bleach baths

Water

PLACEBO COMPARATOR

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

Other: Water

Interventions

Dilute bleach baths OTHER

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

Dilute bleach baths

Water OTHER

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

Water

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Medical Center Dallas: collaborator

Study Sites (1)

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 19403473 RESULT

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 31, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2017
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

US (1)