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 (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

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).

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Imiquimod 5% cream
• Other: 2
  • vehicle cream

Primary Measures

• recuurence rate 24 weeks after ablative therapy
  • Time Frame: 24 weeks
    Safety Issue?: Yes

Secondary Measures

• Time to recurrence
  • Time Frame: n.a.
    Safety Issue?: Yes
• Recurrence rate at 4 and 12 weeks post ablation
  • Time Frame: 4 and 12 weeks
    Safety Issue?: Yes
• Reduction of EGW area
  • Time Frame: 4 and 12 weeks
    Safety Issue?: Yes
• Healing and cosmetic outcome
  • Time Frame: 4, 12 and 24 weeks
    Safety Issue?: Yes
• Local and general tolerability
  • Time Frame: n.a.
    Safety Issue?: Yes
• Percent of complete clearance after initial topical treatment
  • Time Frame: up to 6 weeks after initial topical treatment
    Safety Issue?: Yes
• Occurrence of new lesions
  • Time Frame: n.a.
    Safety Issue?: Yes

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 July 02, 2009

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