Status:
COMPLETED
Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Conditions:
Genital Warts
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 week...
Detailed Description
To compare the recurrence rate 24 weeks after ablative therapy in subjects with external genital warts trated with imiquimod, 3 applications per week for 4 weeks followed by ablative therapy versus ve...
Eligibility Criteria
Inclusion
- Subjects with at least 1 visible genital or perianal wart
- Total wart area 1 to 40 square centimeters.
Exclusion
- Pregnant or lactating women
- Known other sexually transmitted disease
- Evidence of a clinically significant immunodeficiency
- Evidence of unstable cardiovascular, pulmonary, hematological, hepatic, renal, endocrine, collagen vascular, neurological or gastrointestinal abnormality or disease.
- Treatment within the 4 weeks prior to the Randomization Visit with any of the following systemic or topical treatments: interferons, interferon inducers, immunomodulators, immunosuppressive drugs, antiviral drugs (except for systemic acyclovir, valacyclovir and famciclovir), cytotoxic drugs, investigational drugs, or any drugs known to have major organ toxicity.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00189293
Start Date
June 1 2005
End Date
December 1 2007
Last Update
February 7 2022
Active Locations (12)
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1
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
Ancona, Italy, 60123
2
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
Asti, Italy, 14100
3
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico
Bari, Italy, 70100
4
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele
Catania, Italy, 95124