NCT00449982

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (planned)
• Sponsor: MediGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Condylomata Acuminata

Interventions

Type	Name	Description
DRUG	Polyphenon E Ointment 10%, Polyphenon E Ointment 15%

Timeline

• Start date: 2003-07-01
• Completion: 2004-08-01
• First posted: 2007-03-21
• Last updated: 2007-03-21

Locations

12 sites across 7 countries: United States, Argentina, Chile, Colombia, Mexico, Peru, Romania