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A Study of Different Use Regimens Using Two Acne Treatments

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ClinicalTrials.gov Identifier: NCT00907257
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : January 21, 2011
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: benzoyl peroxide wash
Drug: Tretinoin gel
Enrollment 247
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Same Time of Day Different Times of Day
Hide Arm/Group Description 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Period Title: Overall Study
Started 123 124
Completed 110 112
Not Completed 13 12
Reason Not Completed
Adverse Event             0             4
Protocol Violation             1             2
Lost to Follow-up             3             3
Withdrawal by Subject             1             2
Per IRB-Subject became vulnerable             1             0
Moved             1             0
Personal Reasons             6             1
Arm/Group Title Same Time of Day Different Times of Day Total
Hide Arm/Group Description 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening Total of all reporting groups
Overall Number of Baseline Participants 123 124 247
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 124 participants 247 participants
18.5  (6.86) 18.6  (6.94) 18.5  (6.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 124 participants 247 participants
Female
60
  48.8%
66
  53.2%
126
  51.0%
Male
63
  51.2%
58
  46.8%
121
  49.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 123 participants 124 participants 247 participants
123 124 247
Fitzpatrick Score   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 123 participants 124 participants 247 participants
I 8 5 13
II 31 29 60
III 44 52 96
IV 24 22 46
V 8 12 20
VI 8 4 12
[1]
Measure Description: Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI).
1.Primary Outcome
Title Change From Baseline in Total Facial Acne Lesion Count
Hide Description Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.
Arm/Group Title Same Time of Day Different Times of Day
Hide Arm/Group Description:
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Number of Participants Analyzed 109 112
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
39.74  (1.64) 40.02  (1.62)
2.Secondary Outcome
Title Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
Hide Description Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).
Arm/Group Title Same Time of Day Different Times of Day
Hide Arm/Group Description:
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Number of Participants Analyzed 123 124
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
Inflammatory Lesions 14.6  (0.85) 14.2  (0.84)
Non-Inflammatory Lesions 23.2  (1.17) 23.7  (1.16)
Total Lesions 37.4  (1.70) 38.1  (1.68)
3.Secondary Outcome
Title Measurement of Success
Hide Description

Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:

0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)
Arm/Group Title Same Time of Day Different Times of Day
Hide Arm/Group Description:
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Number of Participants Analyzed 123 124
Measure Type: Number
Unit of Measure: Participants
Clear / Almost Clear 26 25
Improved Two Categories 51 54
Time Frame 12 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Same Time of Day Different Times of Day
Hide Arm/Group Description 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
All-Cause Mortality
Same Time of Day Different Times of Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Same Time of Day Different Times of Day
Affected / at Risk (%) Affected / at Risk (%)
Total   3/123 (2.44%)   0/124 (0.00%) 
Cardiac disorders     
Cardiac Arrhythmia * 1  1/123 (0.81%)  0/124 (0.00%) 
Viral Myocarditis * 1  1/123 (0.81%)  0/124 (0.00%) 
Reproductive system and breast disorders     
Ovarian Cyst * 1  1/123 (0.81%)  0/124 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Same Time of Day Different Times of Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)   0/124 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: David Lineberry
Organization: Valeant Pharmaceuticals International, Inc
Phone: 949-973-1153
Publications of Results:
Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00907257     History of Changes
Other Study ID Numbers: CA-P-6270
First Submitted: May 20, 2009
First Posted: May 22, 2009
Results First Submitted: December 22, 2010
Results First Posted: January 21, 2011
Last Update Posted: February 15, 2012