Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00558831
First received: November 13, 2007
Last updated: January 12, 2011
Last verified: January 2011
Results First Received: October 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Benzoyl Peroxide
Drug: Moisturizing Lotion

  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 in this study were patients clinically diagnosed with acne vulgaris. Participants will be recruited from the clinic. Patients were 18 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face.

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
Subjects Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.

Participant Flow:   Overall Study
    Subjects  
STARTED     11  
COMPLETED     10  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  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
Subjects Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.

Baseline Measures
    Subjects  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     8  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures

1.  Primary:   Subject Reported Change From Baseline Scale   [ Time Frame: baseline and 1 month ]


  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: 312-695-6829
e-mail: apaller@nmff.org


No publications provided


Responsible Party: Amy Paller, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00558831     History of Changes
Other Study ID Numbers: STU1884
Study First Received: November 13, 2007
Results First Received: October 12, 2010
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board