Clinical Trial: Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Three-Arm Parallel-Group, Placebo-Controlled Phase 3 Trial to Investigate the Clinical Efficacy and Safety of Polyphenon E in the Treatment of External Genital Warts

Brief Summary: The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

Detailed Summary:

External genital warts are non-malignant tumors caused by infections of the human papillomavirus (HPV), mainly types 6 and 11. Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves.

Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo


Sponsor: MediGene

Current Primary Outcome:

  • Complete clearance of all warts within a maximum of 16 weeks treatment
  • Severe local reaction during the treatment period


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to complete clearance of all warts, of all baseline warts, and of all new warts
  • Partial clearance of warts at the end of treatment
  • Recurrence of any wart during the follow-up period
  • New warts during treatment and the follow-up period
  • Local sings and symptoms at the wart sites
  • Related adverse events during the treatment period


Original Secondary Outcome: Same as current

Information By: MediGene

Dates:
Date Received: March 20, 2007
Date Started: July 2003
Date Completion: August 2004
Last Updated: March 20, 2007
Last Verified: March 2007