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
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
Complete clearance of all warts within a maximum of 16 weeks treatment
Karl R. Beutner, M.D., Ph.D.
Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA
United States: Food and Drug Administration
|Fountain Valley, California 92708|
|Albany, New York 12208|
|Austin, Texas 78705|
|South Burlington, Vermont|