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Epiduo Pediatric Acne Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01138735
First received: June 4, 2010
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Acne
Interventions: Drug: adapalene/benzoyl peroxide
Drug: Topical Gel Vehicle

  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
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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
Adapalene/Benzoyl Peroxide Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle Topical Gel Vehicle applied topically once daily for 12 weeks

Participant Flow:   Overall Study
    Adapalene/Benzoyl Peroxide     Topical Gel Vehicle  
STARTED     142     143  
COMPLETED     134     126  
NOT COMPLETED     8     17  



  Baseline Characteristics
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Reporting Groups
  Description
Adapalene/Benzoyl Peroxide Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle Topical Gel Vehicle applied topically once daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Adapalene/Benzoyl Peroxide     Topical Gel Vehicle     Total  
Number of Participants  
[units: participants]
 		  142     143     285  
Age  
[units: participants]
 		     
<=18 years     142     143     285  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  10.3  ± 0.76     10.4  ± 0.68     10.4  ± 0.72  
Gender  
[units: participants]
 		     
Female     109     108     217  
Male     33     35     68  
Region of Enrollment  
[units: participants]
 		     
United States     130     129     259  
Canada     12     14     26  



  Outcome Measures
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1.  Primary:   Success Rate   [ Time Frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF]) ]
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2.  Primary:   Change From Baseline in Total Lesion Counts   [ Time Frame: Baseline to Week 12 (LOCF) ]
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3.  Secondary:   Percent Change in Total Lesion Counts From Baseline   [ Time Frame: Baseline to Week 12 (LOCF) ]
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4.  Secondary:   Change in Inflammatory Lesion Counts From Baseline   [ Time Frame: Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 4


  Serious Adverse Events
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
LOCF data were used for primary efficacy and secondary efficacy data.  


Results Point of Contact:  
Name/Title: Michael Graeber, MD
Organization: Galderma
phone: 609-860-8201
e-mail: michael.graeber@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01138735     History of Changes
Other Study ID Numbers: RD.06.SPR.18155
Study First Received: June 4, 2010
Results First Received: February 19, 2013
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration