Safety and Effectiveness 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

NCT00674739

Run by

Graceway Pharmaceuticals, LLC

People needed

470

Starts

2008-05-01

Expected to finish

2009-07-01

Last updated by the study team

2011-05-24

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 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

• WILMAX Clinical Research — Mobile, Alabama, United States
• Montgomery Women's Health Associates — Montgomery, Alabama, United States
• Women's Health Research — Phoenix, Arizona, United States
• Precision Trials — Phoenix, Arizona, United States
• Premier Pharmaceutical Research — Tempe, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• Edinger Medical Group Clinical Research Center — Fountain Valley, California, United States
• East Bay Dermatology Medical Group — Fremont, California, United States
• Coastal Medical Research Group — San Luis Obispo, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Clinicos, LLC — Colorado Springs, Colorado, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Discovery Clinical Research — Sunrise, Florida, United States
• Perimeter Institute for Clinical Research — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Atlanta North Gynecology — Roswell, Georgia, United States
• Indiana University Infectious Disease Research Group — Indianapolis, Indiana, United States
• Dermatology Practice — Ann Arbor, Michigan, United States
• Alegent Health Clinic — Omaha, Nebraska, United States
• Private Practice — Great Neck, New York, United States
• Private Practice — Purchase, New York, United States
• State University of NY Stony Brook — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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