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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004654-19 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Imiquimod 5% cream |
|
| 2 | Other | vehicle cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod | Drug | Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| recuurence rate 24 weeks after ablative therapy | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence | ||
| Recurrence rate at 4 and 12 weeks post ablation | 4 and 12 weeks | |
| Reduction of EGW area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fausto Boselli, MD | Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Ostetrica e Ginecologica Università Politecnica delle Marche | Ancona | 60123 | Italy | |||
| Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| vehicle cream |
| Other |
vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s) |
|
| 4 and 12 weeks |
| Healing and cosmetic outcome | 4, 12 and 24 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 |
| Asti |
| 14100 |
| Italy |
| Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico | Bari | 70100 | Italy |
| Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele | Catania | 95124 | Italy |
| Clinica Ostetrica Ginecologica, Ospedale Careggi | Florence | 50134 | Italy |
| Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST | Genova | 16132 | Italy |
| Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento | Milan | 20122 | Italy |
| Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco | Milan | Italy |
| Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia | Modena | 41100 | Italy |
| Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli | Palermo | 90127 | Italy |
| Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie | Pozzuoli | 80078 | Italy |
| Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |