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

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.

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

Inclusion Criteria:

• Age >= 18 years at the time of enrollment
• Clinical diagnosis of external genital warts (located genital, inguinal, perineal or perianal)
• At least 2, but no more than 30 external genital warts
• A total wart area between 12 and 600mm²
• Negative pregnancy test and willingness to use effective contraception (for women of child-bearing potential)
• For partners of male patients who are of child-bearing potential: use of effective contraception during the treatment period
• Written informed consent
• Ability to comply with the requirements of the study

Exclusion Criteria:

• Participation in an investigational trail within 30 days prior to enrollment
• Previous participation in a trial investigating Polyphenon E in the treatment of external genital warts
• Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration
• Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration
• Systemic intake of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment and for the whole study duration
• Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 month
• Any current and/or recurrent pathologically relevant genital infections other than genital warts
• Current known acute or chronic infection with HBV or HCV
• Known HIV infection
• Any current uncontrolled infection
• Organ allograft
• For female patients: pregnancy or lactation
• Known allergies against any of the ingredients of the treatments
• Any chronic or acute skin condition susceptible of interfering with the evaluation of the drug effect
• Any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study
• Internal (vaginal or rectal) warts requiring treatment