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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179959
First Posted: September 16, 2005
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Society for Pediatric Dermatology
Johnson & Johnson
Information provided by (Responsible Party):
Amy Paller, Northwestern University
Results First Submitted: April 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
No text entered.

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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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.
No text entered.

Reporting Groups
  Description
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 Analyzed 
[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 ]


  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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  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.


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:

Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT00179959     History of Changes
Other Study ID Numbers: 12624
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: April 4, 2011
Results First Posted: April 29, 2011
Last Update Posted: December 8, 2014