Condylomata Acuminata Clinical Trial
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
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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