Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Phase 3 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.
Inclusion Criteria:

 -  In good general health

 -  Diagnosis of external genital / perianal warts with at least 2 warts and no more than
 30 warts

 -  Negative pregnancy test (for women who are able to become pregnant)

 Exclusion Criteria:

 -  Women who are pregnant, lactating or planning to become pregnant during the study

 -  Evidence of clinically significant or unstable disease (such as stroke, heart attack)

 -  Have any of the following conditions: HIV infection; current or history of high risk
 HPV infection (e.g., HPV types 16, 18, etc.); outbreak of herpes genitalia in the wart
 areas; internal warts requiring or undergoing treatment; dermatological disease (e.g.,
 psoriasis) or skin condition in the wart areas

 -  Have received specific treatments in the treatment area(s) within the designated time
 period prior to study treatment initiation