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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:
Collaborators:
Society for Pediatric Dermatology
Johnson & Johnson
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT00179959
First received: September 13, 2005
Last updated: November 29, 2012
Last verified: October 2012
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
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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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  
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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Measure Type Primary
Measure Title Change in Eczema Area and Severity Index (EASI)Scores According to Location
Measure Description The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician’s Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician’s Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).
Time Frame Baseline and 3 months  
Safety Issue No  

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.
Analysis was per protocol.

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

Measured Values
    Treatment     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  9     13  
Change in Eczema Area and Severity Index (EASI)Scores According to Location  
[units: Change in EASI Score]
Mean ± Standard Deviation 		   
Exposed Sites: Head and Neck     -1.06  ± 1.04     -0.57  ± 0.86  
Bath-Submerged Sites: Limbs and Trunk     -4.94  ± 0.74     -0.88  ± 0.62  

No statistical analysis provided for Change in Eczema Area and Severity Index (EASI)Scores According to Location




  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
No text entered.  


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
Study First Received: September 13, 2005
Results First Received: April 4, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board