Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts

Completed · Phase 3 · Has a placebo group

Conditions studied: Genital Warts

In brief

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.

Key facts

Study ID

NCT00735462

Run by

Graceway Pharmaceuticals, LLC

People needed

511

Starts

2008-08-01

Expected to finish

2009-07-01

Last updated by the study team

2011-07-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• NEA Clinic — Jonesboro, Arkansas, United States
• Northern Claifornia Research — Carmichael, California, United States
• California State University - Chico — Chico, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Conant Foundation — San Francisco, California, United States
• Downtown Women's Healthcare — Denver, Colorado, United States
• Altus Research — Lake Worth, Florida, United States
• PMI Health Research Group — Atlanta, Georgia, United States
• Atlanta Women's Research Institute — Atlanta, Georgia, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Howard Brown — Chicago, Illinois, United States
• Valley Medical Center — Flint, Michigan, United States
• Women's OB/GYN — Saginaw, Michigan, United States
• Clayton Research Institute — St Louis, Missouri, United States
• Women's Health Research Center — Lawrenceville, New Jersey, United States
• Alliance Women's Research — Riverside Park, New Jersey, United States
• Southwest Clinical Research — Albuquerque, New Mexico, United States
• University Urology Associates — New York, New York, United States
• Boro Park ObGyn — New York, New York, United States
• Crescent Medical Research — Salisbury, North Carolina, United States
• Piedmont Medical Research — Winston-Salem, North Carolina, United States
• Rapid Medical Research — Cleveland, Ohio, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• Wright State University — Dayton, Ohio, United States
• Heartland Health Institute — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.