Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
- Conditions
- Genital Warts
- Interventions
- Registration Number
- NCT00735462
- Lead Sponsor
- Graceway Pharmaceuticals, LLC
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3.75% imiquimod cream 3.75% imiquimod cream 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. 2.5% imiquimod cream 2.5% imiquimod cream 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks Placebo cream Placebo cream Placebo cream applied daily to wart areas for up to 8 weeks.
- Primary Outcome Measures
Name Time Method Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. Up to 16 weeks The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period Up to 16 weeks Treatment related defined as "probably related" or "related" by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.
Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction.
Trial Locations
- Locations (43)
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
PMI Health Research Group
🇺🇸Atlanta, Georgia, United States
Conant Foundation
🇺🇸San Francisco, California, United States
Atlanta Women's Research Institute
🇺🇸Atlanta, Georgia, United States
Howard Brown
🇺🇸Chicago, Illinois, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Tennessee Women's Care
🇺🇸Nashville, Tennessee, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
TMC Life Research
🇺🇸Houston, Texas, United States
Utah Clinical Trials
🇺🇸Salt Lake City, Utah, United States
Women's Clinical Research Center
🇺🇸Seattle, Washington, United States
Wright State University
🇺🇸Dayton, Ohio, United States
Alpha Clinical Research
🇺🇸Clarksville, Tennessee, United States
Northern Claifornia Research
🇺🇸Carmichael, California, United States
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Complete Healthcare for Women
🇺🇸Columbus, Ohio, United States
Palmetto Clinical Research
🇺🇸Greer, South Carolina, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Heartland Health Institute
🇺🇸Tulsa, Oklahoma, United States
Women's OB/GYN
🇺🇸Saginaw, Michigan, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Valley Medical Center
🇺🇸Flint, Michigan, United States
Clinical Trials of America
🇺🇸Eugene, Oregon, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
DiscoveResearch
🇺🇸Bryan, Texas, United States
California State University - Chico
🇺🇸Chico, California, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Downtown Women's Healthcare
🇺🇸Denver, Colorado, United States
Clayton Research Institute
🇺🇸St Louis, Missouri, United States
Alliance Women's Research
🇺🇸Delran, New Jersey, United States
Southwest Clinical Research
🇺🇸Albuquerque, New Mexico, United States
Women's Health Research Center
🇺🇸Lawrenceville, New Jersey, United States
Boro Park ObGyn
🇺🇸New York, New York, United States
University Urology Associates
🇺🇸New York, New York, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
The Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
Adams Patterson Gynecology and Obstetrics
🇺🇸Memphis, Tennessee, United States
West Houston Clinical Research Services
🇺🇸Houston, Texas, United States
The Center for Clinical Studies
🇺🇸Webster, Texas, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Independence Family Medicine Clinical Research
🇺🇸Virginia Beach, Virginia, United States
CARE-ID
🇺🇸Annandale, Virginia, United States
Tidewater Clinical Reseach
🇺🇸Virginia Beach, Virginia, United States