Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis

Moderate to Severe Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01286220
• Other study ID #: STU 012010-059
• Status: Terminated
• Phase: N/A
• Start date: December 2010
• Est. completion date: August 2017

Study information

• Verified date: March 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2017
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate to Severe Atopic Dermatitis

Intervention

Other:
• Dilute bleach baths
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
• Water
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.

Locations

Country	Name	City	State
United States	Children's Medical Center of Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Children's Medical Center Dallas

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Investigator's Global Assessment (IGA)	IGA scores are recorded at baseline, 1 month and 3 month follow ups.	Change in IGA score from baseline at 1 month and 3month follow ups