Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
- Conditions
- Genital Warts
- Interventions
- Registration Number
- NCT00674739
- 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
- 470
- 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 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. placebo cream placebo cream placebo cream applied daily to wart areas for up to 8 weeks imiquimod cream Imiquimod 2.5% imiquimod cream applied daily to wart area for up to 8 weeks
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study Up to 16 weeks Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.
- Secondary Outcome Measures
Name Time Method Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. Up to 16 weeks Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.
Rest period was a temporary interruption of dosing dur to intolerable LSRs.Treatment Related Adverse Events Up to 16 weeks Numbers of subjects in each treatment group reporting one or more adverse events
Trial Locations
- Locations (28)
University of Texas Southwestern Medical Center Dermatology Dept
🇺🇸Dallas, Texas, United States
Dermatology Practice
🇺🇸Ann Arbor, Michigan, United States
Alegent Health Clinic
🇺🇸Omaha, Nebraska, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
WILMAX Clinical Research
🇺🇸Mobile, Alabama, United States
Montgomery Women's Health Associates
🇺🇸Montgomery, Alabama, United States
Premier Pharmaceutical Research
🇺🇸Tempe, Arizona, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
East Bay Dermatology Medical Group
🇺🇸Fremont, California, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Indiana University Infectious Disease Research Group
🇺🇸Indianapolis, Indiana, United States
Clinicos, LLC
🇺🇸Colorado Springs, Colorado, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
Colorado Medical Research Center
🇺🇸Denver, Colorado, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Perimeter Institute for Clinical Research
🇺🇸Atlanta, Georgia, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Professional Quality Research, The Urology Team
🇺🇸Austin, Texas, United States
Coastal Medical Research Group
🇺🇸San Luis Obispo, California, United States
Professional Quality Research, Women Partners in Health
🇺🇸Austin, Texas, United States
Discovery Clinical Research
🇺🇸Sunrise, Florida, United States
Edinger Medical Group Clinical Research Center
🇺🇸Fountain Valley, California, United States
Philadelphia Institute of Dermatology
🇺🇸Philadelphia, Pennsylvania, United States
Atlanta North Gynecology
🇺🇸Roswell, Georgia, United States
Private Practice
🇺🇸Purchase, New York, United States
State University of NY Stony Brook
🇺🇸Stony Brook, New York, United States