Spots Global Cancer Trial Database for Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
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Trial Identification
Brief Title: Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
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
Study ID: NCT00189293
Conditions
Study Description
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 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone.
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 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento, Milano, , Italy
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco, 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, , Italy
Contact Details
Name: Fausto Boselli, MD
Affiliation: Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
Role: PRINCIPAL_INVESTIGATOR
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