Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00787943
First received: November 6, 2008
Last updated: November 19, 2010
Last verified: November 2010
Results First Received: September 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acne Vulgaris
Intervention: Drug: topical benzoyl peroxide 10.0% cream - Formulations #1 and #2

  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
Participants were recruited from the clinic, as well as advertising in the Department of Dermatology.

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
All Study Participants Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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
All Study Participants Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Gender  
[units: Participants]
 
Female     6  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Number of Inflammatory Lesions (Papules and Pustules)   [ Time Frame: 4 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  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: Northwestern University
phone: 773-327-9642
e-mail: apaller@northwestern.edu


No publications provided


Responsible Party: Amy Paller, MD, Northwestern University Department of Dermatology
ClinicalTrials.gov Identifier: NCT00787943     History of Changes
Other Study ID Numbers: AP-032408
Study First Received: November 6, 2008
Results First Received: September 24, 2010
Last Updated: November 19, 2010
Health Authority: United States: Institutional Review Board