Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
- Registration Number
- NCT00189293
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- Subjects with at least 1 visible genital or perianal wart
- Total wart area 1 to 40 square centimeters.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Imiquimod Imiquimod 5% cream 2 vehicle cream vehicle cream
- Primary Outcome Measures
Name Time Method recuurence rate 24 weeks after ablative therapy 24 weeks
- Secondary Outcome Measures
Name Time Method Recurrence rate at 4 and 12 weeks post ablation 4 and 12 weeks Healing and cosmetic outcome 4, 12 and 24 weeks Time to recurrence Reduction of EGW area 4 and 12 weeks Local and general tolerability Percent of complete clearance after initial topical treatment up to 6 weeks after initial topical treatment Occurrence of new lesions
Trial Locations
- Locations (12)
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 di Ostetricia e Ginecologia Ospedale Cardinal Massaia
🇮🇹Asti, 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
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie
🇮🇹Pozzuoli, Italy
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli
🇮🇹Palermo, Italy
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
🇮🇹Ancona, Italy
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy