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Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

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.
 
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
Enrollment 11
Recruitment Details 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  
Arm/Group Title Subjects
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
8
  72.7%
Male
3
  27.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Subject Reported Change From Baseline Scale
Hide Description

-1=worse 0=unchanged

  • 1=mild improvement
  • 2=moderate improvement
  • 3=clear
Time Frame baseline and 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Benzoyl Peroxide 2.5% Cream Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: Participants
-1=Worse 0 0
0=Unchanged 7 6
1=Mild Improvement 1 1
2=Moderate Improvement 1 2
3=Clear 1 1
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benzoyl Peroxide 2.5% Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Benzoyl Peroxide 2.5% Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Benzoyl Peroxide 2.5% Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Benzoyl Peroxide 2.5% Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      6/11 (54.55%)    
Skin and subcutaneous tissue disorders     
Dryness *  6/11 (54.55%)  10 2/11 (18.18%)  3
Burning *  4/11 (36.36%)  4 3/11 (27.27%)  3
Itching *  1/11 (9.09%)  1 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Amy Paller, MD
Organization: Northwestern University
Phone: 312-695-6829
EMail: apaller@nmff.org
Layout table for additonal information
Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT00558831    
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