Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
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|ClinicalTrials.gov Identifier: NCT00735462|
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.
External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
|Condition or disease||Intervention/treatment||Phase|
|Genital Warts||Drug: 2.5% imiquimod cream Drug: 3.75% imiquimod cream Drug: Placebo cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
Drug: 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
Other Name: 2.5% imiquimod topical cream
Experimental: 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
Drug: 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
Other Name: 3.75% imiquimod topical cream
Placebo Comparator: Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks.
Drug: Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks
Other Name: Placebo topical cream
- Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. [ Time Frame: Up to 16 weeks ]The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
- 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 ]
Treatment related defined as "probably related" or "related" by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.
Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735462
|Study Director:||Jason Wu, MD||Graceway Pharmaceuticals|