Genital Warts Clinical Trial
Official title:
Multicenter, Randomised, Double-blind, Vehicle-controlled Study Comparing Recurrence Rate Following Imiquimod 5% Cream or Vehicle 3 Times Per Week for 4 Weeks Prior to Ablative Therapy in Subjects Suffering From External Ano-Genital Warts
Verified date | September 2008 |
Source | Viatris Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone.
Status | Completed |
Enrollment | 128 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects with at least 1 visible genital or perianal wart - Total wart area 1 to 40 square centimeters. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Clinica Ostetrica e Ginecologica Università Politecnica delle Marche | Ancona | |
Italy | Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia | Asti | |
Italy | Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico | Bari | |
Italy | Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele | Catania | |
Italy | Clinica Ostetrica Ginecologica, Ospedale Careggi | Firenze | |
Italy | Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST | Genova | |
Italy | Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco | Milano | |
Italy | Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento | Milano | |
Italy | Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia | Modena | |
Italy | Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli | Palermo | |
Italy | Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie | Pozzuoli | |
Italy | Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore | Roma |
Lead Sponsor | Collaborator |
---|---|
MEDA Pharma GmbH & Co. KG |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recuurence rate 24 weeks after ablative therapy | 24 weeks | ||
Secondary | Time to recurrence | |||
Secondary | Recurrence rate at 4 and 12 weeks post ablation | 4 and 12 weeks | ||
Secondary | Reduction of EGW area | 4 and 12 weeks | ||
Secondary | Healing and cosmetic outcome | 4, 12 and 24 weeks | ||
Secondary | Local and general tolerability | |||
Secondary | Percent of complete clearance after initial topical treatment | up to 6 weeks after initial topical treatment | ||
Secondary | Occurrence of new lesions |
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