Status:
COMPLETED
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Conditions:
Genital Warts
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT00735462
Start Date
August 1 2008
End Date
July 1 2009
Last Update
July 20 2011
Active Locations (43)
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1
NEA Clinic
Jonesboro, Arkansas, United States, 72401
2
Northern Claifornia Research
Carmichael, California, United States, 95608
3
California State University - Chico
Chico, California, United States, 95929
4
Dermatology Research Associates
Los Angeles, California, United States, 90045