NCT00674739

Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Graceway Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Genital Warts

Interventions

Type	Name	Description
DRUG	Imiquimod	daily topical application for up to 8 weeks
DRUG	3.75% imiquimod cream	3.75% imiquimod 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

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-05-08
• Last updated: 2011-05-24
• Results posted: 2011-05-18

Locations

30 sites across 1 country: United States