NCT00189293

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Genital Warts

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-19
• Last updated: 2022-02-07

Locations

12 sites across 1 country: Italy