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Brief Title: Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
Study ID: NCT00674739
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:
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Philadelphia Institute of Dermatology, Philadelphia, Pennsylvania, United States
Professional Quality Research, Women Partners in Health, Austin, Texas, United States
Professional Quality Research, The Urology Team, Austin, Texas, United States
University of Texas Southwestern Medical Center Dermatology Dept, Dallas, Texas, United States
Progressive Clinical Research, San Antonio, Texas, United States
Name: Jason Wu, MD
Affiliation: Graceway Pharmaceuticals
Role: STUDY_DIRECTOR