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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00189293
Other study ID # 1526-IMIQ
Secondary ID 2004-004654-19
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2005
Est. completion date December 2007

Study information

Verified date September 2008
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 128
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Imiquimod
Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)
Other:
vehicle cream
vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)

Locations

Country Name City State
Italy 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 Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco Milano
Italy Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento 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

Sponsors (1)

Lead Sponsor Collaborator
MEDA Pharma GmbH & Co. KG

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary recuurence rate 24 weeks after ablative therapy 24 weeks
Secondary Time to recurrence
Secondary Recurrence rate at 4 and 12 weeks post ablation 4 and 12 weeks
Secondary Reduction of EGW area 4 and 12 weeks
Secondary Healing and cosmetic outcome 4, 12 and 24 weeks
Secondary Local and general tolerability
Secondary Percent of complete clearance after initial topical treatment up to 6 weeks after initial topical treatment
Secondary Occurrence of new lesions
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