The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis

This study has been completed.

Study NCT00179959 Information provided by Northwestern University

First Received on September 13, 2005. Last Updated on May 2, 2011 History of Changes

Results First Received: April 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Atopic Dermatitis
Interventions:	Drug: Sodium hypochlorite (bleach) baths Drug: Mupirocin ointment Drug: Water Drug: Petrolatum Ointment

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from Children's Memorial Hospital's pediatric dermatology clinic.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Treatment	Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
Placebo	Intranasal petrolatum ointment treatment and plain water baths

Participant Flow: Overall Study

	Treatment	Placebo
STARTED	15	16
COMPLETED	9	13
NOT COMPLETED	6	3
Lost to Follow-up	3	1
Withdrawal by Subject	3	2

Baseline Characteristics

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Reporting Groups

	Description
Treatment	Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
Placebo	Intranasal petrolatum ointment treatment and plain water baths

Baseline Measures

	Treatment	Placebo	Total
Number of Participants [units: participants]	15	16	31
Age [units: participants]
<=18 years	15	16	31
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Gender [units: participants]
Female	8	8	16
Male	7	8	15
Region of Enrollment [units: participants]
United States	15	16	31

Outcome Measures

1. Primary:

Change in Eczema Area and Severity Index (EASI)Scores According to Location [ Time Frame: Baseline and 3 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Amy Paller, MD
Organization: Children's Memorial Hospital
phone: 312-695-6829
e-mail: apaller@nmff.org

Publications of Results:

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.

Responsible Party:	Amy Paller, M.D., Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00179959 History of Changes
Other Study ID Numbers:	12624
Study First Received:	September 13, 2005
Results First Received:	April 4, 2011
Last Updated:	May 2, 2011
Health Authority:	United States: Institutional Review Board