Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts

Genital Warts Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• Warts

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