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

This study has been completed.
Society for Pediatric Dermatology
Johnson & Johnson
Information provided by (Responsible Party):
Amy Paller, Northwestern University Identifier:
First received: September 13, 2005
Last updated: November 20, 2014
Last verified: November 2014
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

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Treatment Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
Placebo Intranasal petrolatum ointment treatment and plain water baths
Total Total of all reporting groups

Baseline Measures
    Treatment   Placebo   Total
Overall Participants 
[units: participants]
 15   16   31 
[units: participants]
<=18 years   15   16   31 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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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