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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)
vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
Ancona, Italy
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
Asti, Italy
recuurence rate 24 weeks after ablative therapy
Time frame: 24 weeks
Time to recurrence
Recurrence rate at 4 and 12 weeks post ablation
Time frame: 4 and 12 weeks
Reduction of EGW area
Time frame: 4 and 12 weeks
Healing and cosmetic outcome
Time frame: 4, 12 and 24 weeks
Local and general tolerability
Percent of complete clearance after initial topical treatment
Time frame: up to 6 weeks after initial topical treatment
Occurrence of new lesions
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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
Florence, Italy
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST
Genova, Italy
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
Milan, Italy
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
Milan, 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
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