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Sponsored by: |
MEDA Pharma GmbH & Co. KG |
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Information provided by: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00189293 |
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.
Condition | Intervention | Phase |
---|---|---|
Genital Warts |
Drug: Imiquimod Other: vehicle cream |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 128 |
Study Start Date: | June 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Imiquimod 5% cream
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Drug: Imiquimod
Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s) |
2
vehicle cream
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Other: vehicle cream
vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s) |
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 vehicle, 3 applications per week for 4 weeks followed by ablative therapy. A recurrence is defined as the investoigator-assessed occurrence of lesion(s) within the baseline area cleared by the treatment: imiquimod/vehicle then ablative therapy (either the initial ablative therápy session (A0), or if required for complete clearance of baseline lesions, a second ablative therapy session (A2).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia | |
MODENA, Italy, 41100 | |
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia | |
ASTI, Italy, 14100 | |
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche | |
ANCONA, Italy, 60123 | |
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST | |
GENOVA, Italy, 16132 | |
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico | |
BARI, Italy, 70100 | |
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele | |
CATANIA, Italy, 95124 | |
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco | |
Milano, Italy | |
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento | |
MILANO, Italy, 20122 | |
Clinica Ostetrica Ginecologica, Ospedale Careggi | |
FIRENZE, Italy, 50134 | |
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli | |
PALERMO, Italy, 90127 | |
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore | |
ROMA, Italy, 00168 | |
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie | |
Pozzuoli, Italy, 80078 |
Principal Investigator: | Fausto Boselli, MD | Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia |
Responsible Party: | Meda Pharma GmbH & Co. KG ( Joachim Maus, MD, Director Clinical Development ) |
Study ID Numbers: | 1526-IMIQ, EudraCT: 2004-004654-19 |
Study First Received: | September 12, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00189293 |
Health Authority: | Italy: The Italian Medicines Agency |
External Ano-Genital Warts Ablative Therapy Aldara |
Sexually Transmitted Diseases, Viral Skin Diseases Interferons Condyloma Imiquimod Recurrence Virus Diseases |
Skin Diseases, Infectious Warts Condylomata Acuminata Condyloma acuminatum Sexually Transmitted Diseases Papillomavirus Infections DNA Virus Infections |
Skin Diseases, Viral Interferon Inducers Neoplasms Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Tumor Virus Infections Pharmacologic Actions |