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A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
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.
Details
| Lead sponsor | Graceway Pharmaceuticals, LLC |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 511 |
| Start date | 2008-08 |
| Completion | 2009-07 |
Conditions
- Genital Warts
Interventions
- 2.5% imiquimod cream
- 3.75% imiquimod cream
- Placebo cream
Primary outcomes
- Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. — 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.
Countries
United States