A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
12 Years
N/A
Both
Genital Warts
Trial Information
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety 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 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 With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
Outcome Description:
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.
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:
GW01-0801
NCT ID:
NCT00674739
Start Date:
May 2008
Completion Date:
July 2009
Related Keywords:
- Genital Warts
- external genital warts
- perianal warts
- condylomata acuminata
- venereal warts
- HPV types 6 and 11
- Condylomata Acuminata
- Warts
Name | Location |
|---|---|
| Medical College of Georgia | Augusta, Georgia 30912 |
| Private Practice | Staten Island, New York 10305 |
| Colorado Medical Research Center | Denver, Colorado 80210 |
| Visions Clinical Research | Boynton Beach, Florida 33472 |
| Miami Research Associates | Miami, Florida 33173 |
| Women's Health Research | Phoenix, Arizona 85015 |
| Precision Trials | Phoenix, Arizona 85032 |
| Philadelphia Institute of Dermatology | Fort Washington, Pennsylvania 19034 |
| WILMAX Clinical Research | Mobile, Alabama 36608 |
| Montgomery Women's Health Associates | Montgomery, Alabama 36116 |
| Premier Pharmaceutical Research | Tempe, Arizona 85282 |
| Visions Clinical Research | Tucson, Arizona 85712 |
| Edinger Medical Group Clinical Research Center | Fountain Valley, California 92708 |
| East Bay Dermatology Medical Group | Fremont, California 94538 |
| Coastal Medical Research Group | San Luis Obispo, California 93405 |
| Torrance Clinical Research | Torrance, California 90505 |
| Clinicos, LLC | Colorado Springs, Colorado 80904 |
| Segal Institute for Clinical Research | North Miami, Florida 33161 |
| Discovery Clinical Research | Sunrise, Florida 33316 |
| Perimeter Institute for Clinical Research | Atlanta, Georgia 30338 |
| Atlanta North Gynecology | Roswell, Georgia 30075 |
| Indiana University Infectious Disease Research Group | Indianapolis, Indiana 46202 |
| Dermatology Practice | Ann Arbor, Michigan 48103 |
| Alegent Health Clinic | Omaha, Nebraska 68124 |
| State University of NY Stony Brook | Stony Brook, New York 11794 |
| Professional Quality Research, The Urology Team | Austin, Texas 78759 |
| Professional Quality Research, Women Partners in Health | Austin, Texas 78705 |
| University of Texas Southwestern Medical Center Dermatology Dept | Dallas, Texas 75390 |
| Progressive Clinical Research | San Antonio, Texas 78229 |
