Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
1 other identifier
interventional
511
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
July 20, 2011
CompletedJuly 20, 2011
June 1, 2011
11 months
August 14, 2008
April 24, 2011
June 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Up to 16 weeks
Secondary Outcomes (1)
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
Study Arms (3)
2.5% imiquimod cream
EXPERIMENTAL2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
3.75% imiquimod cream
EXPERIMENTAL3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
Placebo cream
PLACEBO COMPARATORPlacebo cream applied daily to wart areas for up to 8 weeks.
Interventions
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
Placebo cream applied daily to wart areas for up to 8 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Northern Claifornia Research
Carmichael, California, 95608, United States
California State University - Chico
Chico, California, 95929, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Conant Foundation
San Francisco, California, 94114, United States
Downtown Women's Healthcare
Denver, Colorado, 80218, United States
Altus Research
Lake Worth, Florida, 33461, United States
PMI Health Research Group
Atlanta, Georgia, 30312, United States
Atlanta Women's Research Institute
Atlanta, Georgia, 30342, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 61614, United States
Howard Brown
Chicago, Illinois, 60613, United States
Valley Medical Center
Flint, Michigan, 48507, United States
Women's OB/GYN
Saginaw, Michigan, 48604, United States
Clayton Research Institute
St Louis, Missouri, 63107, United States
Women's Health Research Center
Lawrenceville, New Jersey, 08648, United States
Alliance Women's Research
Riverside Park, New Jersey, 08075, United States
Southwest Clinical Research
Albuquerque, New Mexico, 87102, United States
University Urology Associates
New York, New York, 10016, United States
Boro Park ObGyn
New York, New York, 10121, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Complete Healthcare for Women
Columbus, Ohio, 43213, United States
Wright State University
Dayton, Ohio, 45408, United States
Heartland Health Institute
Tulsa, Oklahoma, 74105, United States
Clinical Trials of America
Eugene, Oregon, 97401, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Palmetto Clinical Research
Greer, South Carolina, 29650, United States
Alpha Clinical Research
Clarksville, Tennessee, 37043, United States
Adams Patterson Gynecology and Obstetrics
Memphis, Tennessee, 38102, United States
Tennessee Women's Care
Nashville, Tennessee, 37203, United States
DiscoveResearch
Bryan, Texas, 77802, United States
TMC Life Research
Houston, Texas, 77054, United States
West Houston Clinical Research Services
Houston, Texas, 77055, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
The Center for Clinical Studies
Webster, Texas, 77058, United States
Utah Clinical Trials
Salt Lake City, Utah, 84107, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
CARE-ID
Annandale, Virginia, 22003, United States
Tidewater Clinical Reseach
Virginia Beach, Virginia, 23456, United States
Independence Family Medicine Clinical Research
Virginia Beach, Virginia, 23513, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
There was a high percentage of lost to follow up in this study. Since the disease studied in this study can be wait and watch, typically a high lost to follow up rate were seen in these kind of trials.
Results Point of Contact
- Title
- Robert Babilon, Vice President, Product Development
- Organization
- Graceway Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Jason Wu, MD
Graceway Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 20, 2011
Results First Posted
July 20, 2011
Record last verified: 2011-06