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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Imiquimod

Primary Measures

• Recurrence rate at 24 weeks after ablative therapy

Secondary Measures

• Time to recurrence
• Recurrence rate at 4 and 12 weeks post ablation
• Reduction of EGW area
• Healing and cosmetic outcome
• Local and general tolerability
• Percent of complete clearance after initial topical treatment
• Occurrence of new lesions

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MEDA Pharma GmbH & Co. KG

Overall Clinical Trial Officials and Contacts

Fausto Boselli, MD Principal Investigator Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00189293

Study ID Number: 1526-IMIQ

ClinicalTrials.gov Identifier: NCT00189293

Health Authority: Italy: The Italian Medicines Agency