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A Study of Different Use Regimens Using Two Acne Treatments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00907257
First received: May 20, 2009
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
Results First Received: December 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: benzoyl peroxide wash
Drug: Tretinoin gel

  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
No text entered.

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
Same Time of Day 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Different Times of Day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Participant Flow:   Overall Study
    Same Time of Day     Different Times of Day  
STARTED     123     124  
COMPLETED     110     112  
NOT COMPLETED     13     12  
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  



  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.
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Reporting Groups
  Description
Same Time of Day 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Different Times of Day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Total Total of all reporting groups

Baseline Measures
    Same Time of Day     Different Times of Day     Total  
Number of Participants  
[units: participants]
 		  123     124     247  
Age  
[units: years]
Mean ± Standard Deviation 		  18.5  ± 6.86     18.6  ± 6.94     18.5  ± 6.89  
Gender  
[units: participants]
 		     
Female     60     66     126  
Male     63     58     121  
Region of Enrollment  
[units: participants]
 		     
United States     123     124     247  
Fitzpatrick Score [1]
[units: 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] 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).



  Outcome Measures
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1.  Primary:   Change From Baseline in Total Facial Acne Lesion Count   [ Time Frame: Baseline to Week 12 ]
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2.  Secondary:   Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals   [ Time Frame: Baseline to Week 12 ]
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3.  Secondary:   Measurement of Success   [ Time Frame: Baseline to Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: David.Lineberry@valeant.com


Publications of Results:


Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00907257     History of Changes
Other Study ID Numbers: CA-P-6270
Study First Received: May 20, 2009
Results First Received: December 22, 2010
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board