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

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ClinicalTrials.gov Identifier: NCT00787943
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : November 17, 2010
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Topical benzoyl peroxide 10.0% cream - Formulation 1
Drug: Topical benzoyl peroxide 10.0% cream - Formulation 2
Enrollment 10
Recruitment Details Participants were recruited from the clinic, as well as advertising in the Department of Dermatology.
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Number of Inflammatory Lesions (Papules and Pustules)
Hide Description Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.
Arm/Group Title Papules: Benzoyl Peroxide 10.0% Cream Formulation #1 Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1 Papules: Benzoyl Peroxide 10.0% Cream Formulation #2 Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2
Hide Arm/Group Description:
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
Overall Number of Participants Analyzed 10 10 10 10
Measure Type: Number
Unit of Measure: Lesions
Subject 1 Day 0 6 3 10 0
Subject 1 Day 2 1 0 5 1
Subject 1 Day 7 1 0 1 0
Subject 1 Day 28 6 1 4 2
Subject 2 Day 0 14 2 7 0
Subject 2 Day 2 15 1 12 2
Subject 2 Day 7 7 0 4 0
Subject 2 Day 28 7 0 8 9
Subject 3 Day 0 7 0 9 6
Subject 3 Day 2 8 0 7 0
Subject 3 Day 7 5 3 11 1
Subject 3 Day 28 8 0 0 1
Subject 4 Day 0 14 4 6 1
Subject 4 Day 2 20 1 4 1
Subject 4 Day 7 21 0 7 1
Subject 4 Day 28 10 1 9 1
Subject 5 Day 0 23 1 23 2
Subject 5 Day 2 26 18 28 21
Subject 5 Day 7 31 0 31 4
Subject 5 Day 28 26 1 29 2
Subject 6 Day 0 22 2 6 3
Subject 6 Day 2 14 0 6 2
Subject 6 Day 7 10 1 10 1
Subject 6 Day 28 12 1 11 0
Subject 7 Day 0 34 6 30 5
Subject 7 Day 2 47 3 34 7
Subject 7 Day 7 46 3 53 1
Subject 7 Day 28 35 6 33 4
Subject 8 Day 0 9 1 7 1
Subject 8 Day 2 11 0 5 0
Subject 8 Day 7 10 0 3 0
Subject 8 Day 28 6 0 7 0
Subject 9 Day 0 17 1 19 1
Subject 9 Day 2 21 0 19 0
Subject 9 Day 7 22 0 14 0
Subject 9 Day 28 13 0 11 0
Subject 10 Day 0 13 2 13 4
Subject 10 Day 2 15 0 18 1
Subject 10 Day 7 13 1 7 2
Subject 10 Day 28 6 1 9 0
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benzoyl Peroxide 10.0% Cream Formulation #1 Benzoyl Peroxide 10.0% Cream: Formulation #2
Hide Arm/Group Description Formulation #1 applied to one side of the face by all 10 subjects. Formulation #2 applied to one side of the face by all 10 subjects.
All-Cause Mortality
Benzoyl Peroxide 10.0% Cream Formulation #1 Benzoyl Peroxide 10.0% Cream: Formulation #2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Benzoyl Peroxide 10.0% Cream Formulation #1 Benzoyl Peroxide 10.0% Cream: Formulation #2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Benzoyl Peroxide 10.0% Cream Formulation #1 Benzoyl Peroxide 10.0% Cream: Formulation #2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/10 (80.00%)      8/10 (80.00%)    
Skin and subcutaneous tissue disorders     
Burning/Stinging   8/10 (80.00%)  40 8/10 (80.00%)  40
Indicates events were collected by systematic assessment
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: 312-695-3721
EMail: apaller@northwestern.edu
Layout table for additonal information
Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT00787943     History of Changes
Other Study ID Numbers: AP-032408
First Submitted: November 6, 2008
First Posted: November 10, 2008
Results First Submitted: September 24, 2010
Results First Posted: November 17, 2010
Last Update Posted: May 1, 2015