Clinical trial NCT00189293: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Genital Warts
Keywords: External Ano-Genital Warts
Ablative Therapy
Aldara
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Subjects with at least 1 visible genital or perianal wart
* Total wart area 1 to 40 square centimeters.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: recuurence rate 24 weeks after ablative therapy
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to recurrence
measure: Recurrence rate at 4 and 12 weeks post ablation
timeFrame: 4 and 12 weeks
measure: Reduction of EGW area
timeFrame: 4 and 12 weeks
measure: Healing and cosmetic outcome
timeFrame: 4, 12 and 24 weeks
measure: Local and general tolerability
measure: Percent of complete clearance after initial topical treatment
timeFrame: up to 6 weeks after initial topical treatment
measure: Occurrence of new lesions
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
city: Asti
country: Italy
facility: Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
city: Bari
country: Italy
facility: Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico
city: Catania
country: Italy
facility: Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele
city: Firenze
country: Italy
facility: Clinica Ostetrica Ginecologica, Ospedale Careggi
city: Genova
country: Italy
facility: Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST
city: Milano
country: Italy
facility: Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
city: Milano
country: Italy
facility: Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
city: Modena
country: Italy
facility: Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
city: Palermo
country: Italy
facility: Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli
city: Pozzuoli
country: Italy
facility: Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie
city: Roma
country: Italy
facility: Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore
Study officials:
affiliation: Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
name: Fausto Boselli, MD
role: PRINCIPAL_INVESTIGATOR
References: