Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00735462
First received: August 14, 2008
Last updated: June 21, 2011
Last verified: June 2011
Results First Received: April 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Genital Warts
Interventions: Drug: 2.5% imiquimod cream
Drug: 3.75% imiquimod cream
Drug: Placebo cream

  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
No text entered.

Reporting Groups
  Description
2.5% Imiquimod Cream 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
3.75% Imiquimod Cream 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
Placebo Placebo cream applied once daily to wart areas for up to 8 weeks.

Participant Flow:   Overall Study
    2.5% Imiquimod Cream     3.75% Imiquimod Cream     Placebo  
STARTED     202     204     105  
COMPLETED     139     149     77  
NOT COMPLETED     63     55     28  



  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
2.5% Imiquimod Cream 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
3.75% Imiquimod Cream 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
Placebo Placebo cream applied once daily to wart areas for up to 8 weeks.
Total Total of all reporting groups

Baseline Measures
    2.5% Imiquimod Cream     3.75% Imiquimod Cream     Placebo     Total  
Number of Participants  
[units: participants]
  202     204     105     511  
Age  
[units: participants]
       
<=18 years     1     2     0     3  
Between 18 and 65 years     201     201     104     506  
>=65 years     0     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  33.1  ± 10.1     32.8  ± 11.0     33.3  ± 10.8     33.1  ± 10.6  
Gender  
[units: participants]
       
Female     117     116     56     289  
Male     85     88     49     222  
Region of Enrollment  
[units: participants]
       
United States     202     204     105     511  



  Outcome Measures
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1.  Primary:   Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.   [ Time Frame: Up to 16 weeks ]

2.  Secondary:   Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period   [ Time Frame: Up to 16 weeks ]


  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
There was a high percentage of lost to follow up in this study. Since the disease studied in this study can be wait and watch, typically a high lost to follow up rate were seen in these kind of trials.  


Results Point of Contact:  
Name/Title: Robert Babilon, Vice President, Product Development
Organization: Graceway Pharmaceuticals
phone: 267-948-0400 ext 20428
e-mail: robert.babilon@gracewaypharma.com


No publications provided


Responsible Party: Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00735462     History of Changes
Other Study ID Numbers: GW01-0805
Study First Received: August 14, 2008
Results First Received: April 24, 2011
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration