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Objective Clinical efficacy and safety of Polyphenon® E, a defined green tea extract, in external genital warts. Design Randomized, double-blind, placebo-controlled study for up to 12 weeks with a 12-week treatment-free follow-up. Setting Twenty-eight hospitals and practices in Germany and Russia. Patients Two hundred forty-two outpatients (125 men, 117 women) with 2 to 30 warts (total wart area, 12–600 mm2). Intervention(s) Topical application of Polyphenon® E 10% Cream, Polyphenon® E 15% Ointment or placebo to all external genital warts three times a day. Main outcome measure(s) Measurement of total wart area and local reactions/adverse events. Results For 15% ointment, statistically significant differences to placebo were achieved regarding complete clearance of all baseline external genital warts (61.0% vs. 40.5% in males, 56.8% vs. 34.1% in females; combined gender: P = 0.0066) and 75% to 100% clearance (80.8% vs. 51.8%; P = 0.0001) in both the intent-to-treat and per-protocol populations. For 10% cream, 53.8% males and 39.5% females achieved complete clearance. Recurrence rates 12 weeks after end of treatment were 10.6%, 11.8% and 10.3% for 15% ointment, 10% cream and placebo, respectively. Adverse events were observed in only 7.9% of patients, with no serious adverse events or deaths reported. Local skin reactions were generally mild to moderate and resolved with continued treatment without sequelae. Conclusions Polyphenon® E 15% ointment, composed of a defined green tea extract, proved to be efficacious and safe for both gender in the treatment of external genital warts. [ABSTRACT FROM AUTHOR]