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Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00558831
Recruitment Status : Completed
First Posted : November 15, 2007
Results First Posted : November 22, 2010
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Benzoyl Peroxide
Drug: Moisturizing Lotion

  Participant Flow

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
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.

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



  Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 		 11 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      11 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      8  72.7% 
Male      3  27.3% 
Region of Enrollment 
[Units: Participants]
 		 
United States   11 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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



Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT00558831     History of Changes
Other Study ID Numbers: STU1884
First Submitted: November 13, 2007
First Posted: November 15, 2007
Results First Submitted: October 12, 2010
Results First Posted: November 22, 2010
Last Update Posted: September 26, 2017