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

J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12. doi: 10.1111/j.1468-3083.2007.02441.x.


Objective: Clinical efficacy and safety of Polyphenon(R) 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 mm(2)). 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(R) 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.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Catechin / analogs & derivatives*
  • Catechin / chemistry
  • Catechin / therapeutic use
  • Condylomata Acuminata / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Ointments
  • Placebos
  • Prognosis
  • Statistics, Nonparametric
  • Treatment Outcome


  • Ointments
  • Placebos
  • Catechin
  • polyphenon E