title: 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.
abstract: OBJECTIVE
  Clinical efficacy and safety of Polyphenon(R) E, a defined green tea extract, in external genital warts.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled study for up to 12 weeks with a 12-week treatment-free follow-up.
  
  
  METHODS
  Twenty-eight hospitals and practices in Germany and Russia.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Dermatology and Venereology, University of Rostock, Rostock, Germany. gerd.gross@med.uni-rostock.de
authors.forename: G
authors.initials: G
authors.lastname: Gross
authors.forename: K-G
authors.initials: KG
authors.lastname: Meyer
authors.forename: H
authors.initials: H
authors.lastname: Pres
authors.forename: C
authors.initials: C
authors.lastname: Thielert
authors.forename: H
authors.initials: H
authors.lastname: Tawfik
authors.forename: A
authors.initials: A
authors.lastname: Mescheder
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002392:Catechin / Q000031:analogs & derivatives* / Q000737:chemistry / Q000627:therapeutic use; D003218:Condylomata Acuminata / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010919:Placebos; D011379:Prognosis; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D009824:Ointments; D010919:Placebos; D002392:Catechin; C472086:polyphenon E