Conditions: Genital Warts
Keywords: external genital warts perianal warts condylomata acuminata human papilloma virus HPV types 6 and 11
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 511
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks arm 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. arm 3: Placebo cream applied daily to wart areas for up to 8 weeks.

Interventions: intervention 1: 2.5% imiquimod cream intervention 2: 3.75% imiquimod cream intervention 3: Placebo cream
Intervention descriptions: intervention 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks. intervention 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks intervention 3: Placebo cream applied daily to wart areas for up to 8 weeks

Protocol document: