A randomized, double-blind, four-arm parallel-group, placebo-controlled Phase II/III study to investigate the clinical efficacy of two galenic formulations of Polyphenon® E in the treatment of external genital warts


  • Funding/Support: This study was supported by Medigene AG, Munich, Germany.

*Corresponding author, Department of Dermatology and Venereology, University of Rostock, Augustenstr. 80–84, D-18055 Rostock, Germany, tel. +49 381 49 49 701; fax +49 381 49 49 702; E-mail: gerd.gross@med.uni-rostock.de


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.