A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Phase 3
12 Years
N/A
12 Years
N/A
Not Enrolling
Both
Genital Warts
Both
Genital Warts
Trial Information
A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
Outcome Description:
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Outcome Time Frame:
Up to 16 weeks
Safety Issue:
No
Principal Investigator
Jason Wu, MD
Investigator Role:
Study Director
Investigator Affiliation:
Graceway Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
GW01-0805
NCT ID:
NCT00735462
Start Date:
August 2008
Completion Date:
July 2009
Related Keywords:
- Genital Warts
- external genital warts
- perianal warts
- condylomata acuminata
- human papilloma virus
- HPV types 6 and 11
- Condylomata Acuminata
- Warts
Name | Location |
|---|---|
| Urology San Antonio Research | San Antonio, Texas 78229 |
| NEA Clinic | Jonesboro, Arkansas 72401 |
| Wright State University | Dayton, Ohio 45408 |
| University Urology Associates | New York, New York 10016 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| Southwest Clinical Research | Albuquerque, New Mexico 87102 |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Complete Healthcare for Women | Columbus, Ohio 43231 |
| Piedmont Medical Research | Winston-Salem, North Carolina 27103 |
| PMI Health Research Group | Atlanta, Georgia 30312 |
| Palmetto Clinical Research | Summerville, South Carolina 29485 |
| West Houston Clinical Research Services | Houston, Texas 77055 |
| Northern Claifornia Research | Carmichael, California 95608 |
| California State University - Chico | Chico, California 95929 |
| Conant Foundation | San Francisco, California 94114 |
| Downtown Women's Healthcare | Denver, Colorado 80218 |
| Altus Research | Lake Worth, Florida 33461 |
| Atlanta Women's Research Institute | Atlanta, Georgia 30342 |
| Howard Brown | Chicago, Illinois 60613 |
| Valley Medical Center | Flint, Michigan 48507 |
| Women's OB/GYN | Saginaw, Michigan 48604 |
| Clayton Research Institute | St Louis, Missouri 63107 |
| Alliance Women's Research | Delran, New Jersey 08075 |
| Women's Health Research Center | Lawrenceville, New Jersey 08648 |
| Boro Park ObGyn | New York, New York 10121 |
| Crescent Medical Research | Salisbury, North Carolina 28144 |
| Rapid Medical Research | Cleveland, Ohio 44122 |
| Heartland Health Institute | Tulsa, Oklahoma 74105 |
| Clinical Trials of America | Eugene, Oregon 97401 |
| Westover Heights Clinic | Portland, Oregon 97210 |
| The Clinical Trial Center | Jenkintown, Pennsylvania 19046 |
| Alpha Clinical Research | Clarksville, Tennessee 37043 |
| Adams Patterson Gynecology and Obstetrics | Memphis, Tennessee 38102 |
| Tennessee Women's Care | Nashville, Tennessee 37203 |
| DiscoveResearch | Bryan, Texas 77802 |
| TMC Life Research | Houston, Texas 77054 |
| The Center for Clinical Studies | Webster, Texas 77058 |
| Utah Clinical Trials | Salt Lake City, Utah 84107 |
| Wasatch Clinical Research | Salt Lake City, Utah 84107 |
| CARE-ID | Annandale, Virginia 22003 |
| Tidewater Clinical Reseach | Virginia Beach, Virginia 23456 |
| Independence Family Medicine Clinical Research | Virginia Beach, Virginia 23513 |
| Women's Clinical Research Center | Seattle, Washington 98105 |
