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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01286220
Other study ID # STU 012010-059
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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