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A Study of Acne Treatment in Children Ages 9 to 11

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00907335
First received: May 20, 2009
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
Results First Received: November 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Retin-A Micro 0.04% facial acne treatment
Drug: Vehicle control

  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
Retin-A Micro Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control Color matched facial gel vehicle control used once daily

Participant Flow:   Overall Study
    Retin-A Micro     Vehicle Control  
STARTED     55     55  
COMPLETED     47     54  
NOT COMPLETED     8     1  
Withdrawal by Subject                 2                 0  
Adverse Event                 4                 1  
Lost to Follow-up                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Retin-A Micro Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control Color matched facial gel vehicle control used once daily
Total Total of all reporting groups

Baseline Measures
    Retin-A Micro     Vehicle Control     Total  
Number of Participants  
[units: participants]
 		  55     55     110  
Age, Customized  
[units: participants]
 		     
9 years     5     4     9  
10 Years     21     17     38  
11 Years     29     34     63  
Gender  
[units: participants]
 		     
Female     44     38     82  
Male     11     17     28  
Region of Enrollment  
[units: participants]
 		     
United States     55     55     110  
Subject Reached Puberty  
[units: Participants]
 		     
Yes     17     21     38  
No     38     34     72  
Fitzpatrick Score [1]
[units: Participants]
 		     
I     2     1     3  
II     17     12     29  
III     11     16     27  
IV     14     15     29  
V     8     9     17  
VI     3     2     5  
[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 Non-inflammatory Lesion Count   [ Time Frame: Baseline to Week 12 ]
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2.  Secondary:   Change From Baseline in Lesion Counts   [ Time Frame: Baseline to Week 12 ]
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3.  Secondary:   Measurement of Success 1   [ Time Frame: Week 12 ]
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4.  Secondary:   Measurement of Success 2   [ Time Frame: Week 12 ]
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5.  Secondary:   Measurement of Success 3   [ Time Frame: Week 12 ]
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6.  Secondary:   Global Assessment   [ Time Frame: Baseline to Week 12 ]
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  Serious Adverse Events
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Time Frame 12 Weeks
Additional Description Subjects asked if they experienced adverse events at each visit.

Reporting Groups
  Description
Retin-A Micro Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control Color matched facial gel vehicle control used once daily

Serious Adverse Events
    Retin-A Micro     Vehicle Control  
Total, serious adverse events      
# participants affected / at risk     0/55 (0.00%)     1/55 (1.82%)  
Gastrointestinal disorders      
Appendicitis * 1    
# participants affected / at risk     0/55 (0.00%)     1/55 (1.82%)  
# events     0     1  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (11.1)




  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: David Lineberry, Associate Director, Clinical Operations
Organization: Valeant Pharmaceuticals International, Inc
phone: 949-973-1153
e-mail: David.Lineberry@valeant.com


No publications provided by Valeant Pharmaceuticals International, Inc.

Publications automatically indexed to this study:


Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00907335     History of Changes
Other Study ID Numbers: CA-P-6397
Study First Received: May 20, 2009
Results First Received: November 30, 2010
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration