Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01044264
First received: January 4, 2010
Last updated: January 17, 2013
Last verified: January 2013
Results First Received: September 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Drug: Placebo

  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
FIRST PATIENT ENROLLED: 12/11/2007 LAST PATIENT COMPLETED: 9/18/2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Test product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Reference product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Placebo Placebo : Placebo

Participant Flow:   Overall Study
    1% Clindamycin/5% Benzoyl Peroxide Topical Gel     DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel     Placebo  
STARTED     200     202     200  
COMPLETED     110     108     108  
NOT COMPLETED     90     94     92  



  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.
No text entered.

Reporting Groups
  Description
1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Test product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Reference product

1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel

Placebo Placebo : Placebo
Total Total of all reporting groups

Baseline Measures
    1% Clindamycin/5% Benzoyl Peroxide Topical Gel     DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel     Placebo     Total  
Number of Participants  
[units: participants]
  200     202     200     602  
Age  
[units: participants]
       
<=18 years     117     113     113     343  
Between 18 and 65 years     83     89     87     259  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  19.2  ± 7.3     19.5  ± 7.1     20.1  ± 8.3     19.6  ± 7.6  
Gender  
[units: participants]
       
Female     103     101     113     317  
Male     97     101     87     285  
Region of Enrollment  
[units: participants]
       
United States     200     202     200     602  



  Outcome Measures

1.  Primary:   Reduction of Inflammatory Lesions   [ Time Frame: Baseline and week 11 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Manager
Organization: Perrigo Company
phone: 718-960-0119
e-mail: jonathan.schwartz@perrigo.com


No publications provided


Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01044264     History of Changes
Obsolete Identifiers: NCT00807638
Other Study ID Numbers: DAC-501-601-727998
Study First Received: January 4, 2010
Results First Received: September 14, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board