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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
Unnamed facility
Davis, San Diego, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Portland, Oregon, United States
Complete clearance of all warts within a maximum of 16 weeks treatment
Severe local reaction during the treatment period
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
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Unnamed facility
Houston, Dallas, Austin, Texas, United States
Unnamed facility
Burlington, Vermont, United States
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Santiago, Temuco, Chile
Unnamed facility
Colombia, Bogota, Medellin, Risaralda, Colombia
Unnamed facility
Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla, Mexico
...and 2 more locations