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Polyphenon E ® : a new treatment for external anogenital warts
Author(s) -
Tatti S.,
Stockfleth E.,
Beutner K.R.,
Tawfik H.,
Elsasser U.,
Weyrauch P.,
Mescheder A.
Publication year - 2010
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2009.09375.x
Subject(s) - medicine , library science , humanities , history , art , computer science
Summary Background External genital warts (EGWs, condylomata acuminata) are a common, highly contagious disease caused by human papillomavirus (HPV), predominantly HPV 6 and HPV 11. Green tea catechins have been identified for their immunostimulatory, antiproliferative and antitumour properties. Two phase III trials evaluated treatment of EGWs with ointment containing a mixture of green tea catechins (Polyphenon E ® , U.S. adopted name: sinecatechins). Objectives To obtain additional data on the efficacy and safety of Polyphenon E ® ointment in the treatment of EGWs from two randomized, double‐blind, vehicle‐controlled trials. Methods Men and women aged ≥ 18 years ( n = 1005), with two to 30 EGWs (12–600 mm 2 total area) applied vehicle (G Veh ; n = 207), Polyphenon E ® ointment 10% (G 10% ; n = 401) or Polyphenon E ® ointment 15% (G 15% ; n = 397) three times daily until complete clearance of all EGWs (baseline + new EGWs) or for a maximum of 16 weeks. Results A total of 1004 patients were evaluable for safety and 986 for efficacy; 838 completed treatment after 16 weeks. Complete clearance of all EGWs was obtained in 53·6% (G 10% ) and 54·9% (G 15% ) of patients with Polyphenon E ® vs. vehicle (35·4%) ( P < 0·001). Statistically significant differences in clearance rates appeared after 6 weeks of active treatment. Odds ratios vs. G Veh for G 10% [2·10; 95% confidence interval (CI) 1·49–2·98] and G 15% (2·22; 95% CI 1·57–3·14) indicated about a twofold higher chance of complete clearance under active treatment. Time to complete clearance was shorter with active treatment (hazard ratios 1·57 and 1·87, respectively, for G 10% and G 15% vs. G Veh groups; P < 0·001). Recurrence rates during follow‐up were low and similar across groups: 5·8%, 6·8% and 6·5% (G Veh , G 10% and G 15% groups, respectively). Adverse events were evenly distributed across groups (∼ 30% of patients). Severe local signs were more frequent but moderate in the active treatment groups (1·5%, 9·2% and 13·5% for G Veh , G 10% and G 15% groups, respectively). Conclusions Polyphenon E ® ointment is effective and well tolerated in the treatment of EGWs.