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A Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

This study has been completed.
Sponsor:
Information provided by:
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00828568
First received: January 22, 2009
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
Results First Received: September 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: Imiquimod 5% manufactured by Taro
Drug: Aldara - Imiquimod 5%
Drug: Imiquimod Vehicle manufactured by Taro

  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
Patients were recruited at 20 dermatology clinical practices.

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
Imiquimod 5% Taro Imiquimod 5% manufactured by Taro applied for 16 weeks
Aldara - Imiquimod 5% Aldara, Imiquimod 5% applied for 16 weeks
Vehicle Patients receiving imiquimod Vehicle for 16 weeks

Participant Flow for 2 periods

 Period 1:   Randomized
    Imiquimod 5% Taro     Aldara - Imiquimod 5%     Vehicle  
STARTED     184     179     62  
COMPLETED     183     179     60  
NOT COMPLETED     1     0     2  
Withdrawal by Subject                 1                 0                 2  

Period 2:   Treated - Received at Least One Dose
    Imiquimod 5% Taro     Aldara - Imiquimod 5%     Vehicle  
STARTED     183     179     60  
COMPLETED     153     150     55  
NOT COMPLETED     30     29     5  
Adverse Event                 11                 8                 1  
Withdrawal by Subject                 9                 11                 0  
Lost to Follow-up                 1                 5                 1  
Protocol Violation                 9                 5                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Imiquimod 5% Taro Imiquimod 5% manufactured by Taro applied for 16 weeks
Aldara - Imiquimod 5% Aldara, Imiquimod 5% applied for 16 weeks
Vehicle Patients receiving imiquimod Vehicle for 16 weeks
Total Total of all reporting groups

Baseline Measures
    Imiquimod 5% Taro     Aldara - Imiquimod 5%     Vehicle     Total  
Number of Participants  
[units: participants]
 		  183     179     60     422  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     71     73     27     171  
>=65 years     112     106     33     251  
Age  
[units: years]
Mean ± Standard Deviation 		  68.0  ± 9.5     67.2  ± 10.1     64.7  ± 9.7     67.2  ± 9.8  
Gender  
[units: participants]
 		       
Female     34     33     8     75  
Male     149     146     52     347  
Region of Enrollment  
[units: participants]
 		       
United States     183     179     60     422  



  Outcome Measures
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1.  Primary:   Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%   [ Time Frame: 24 weeks ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline   [ Time Frame: 24 weeks ]
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3.  Secondary:   Patients Reporting at Least One Adverse Event   [ Time Frame: 24 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame Assessed at 24 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Imiquimod 5% Taro Imiquimod 5% manufactured by Taro applied for 16 weeks
Aldara - Imiquimod 5% Aldara, Imiquimod 5% applied for 16 weeks
Vehicle Patients receiving imiquimod Vehicle for 16 weeks

Other Adverse Events
    Imiquimod 5% Taro     Aldara - Imiquimod 5%     Vehicle  
Total, other (not including serious) adverse events        
# participants affected / at risk     22/183     22/179     4/60  
General disorders        
APPLICATION SITE ERYTHEMA 1      
# participants affected / at risk     11/183 (6.01%)     8/179 (4.47%)     0/60 (0.00%)  
# events     12     8     0  
APPLICATION SITE IRRITATION 1      
# participants affected / at risk     5/183 (2.73%)     9/179 (5.03%)     0/60 (0.00%)  
# events     5     9     0  
APPLICATION SITE PRURITUS 1      
# participants affected / at risk     9/183 (4.92%)     9/179 (5.03%)     1/60 (1.67%)  
# events     9     9     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
SQUAMOUS CELL CARCINOMA 1      
# participants affected / at risk     1/183 (0.55%)     1/179 (0.56%)     3/60 (5.00%)  
# events     1     1     5  
1 Term from vocabulary, MedDRA (11.1)



  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 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: Medical Director
Organization: Taro Pharmaceuticals USA
phone: (914) 345-9001 ext 6427
e-mail: medical.affairs@taro.com


No publications provided


Responsible Party: Medical Director, Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00828568     History of Changes
Other Study ID Numbers: MIQ-0403
Study First Received: January 22, 2009
Results First Received: September 17, 2009
Last Updated: November 30, 2009
Health Authority: United States: Institutional Review Board