Polyphenon E 10% ointment: in immunocompetent adults with external genital and perianal warts.
Polyphenon E 10% ointment, which contains a mixture of green tea catechins, is indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients aged ≥18 years. In two double-blind, multinational studies in adults with external genital and perianal warts, polyphenon E 10% ointment for up to 16 weeks was significantly more effective than vehicle with regard to the complete clearance of all warts (i.e. those at baseline and newly appearing during treatment) [primary endpoint]. In gender subgroup analyses, polyphenon E 10% ointment was more effective than vehicle in both men and women in one of two individual studies, and in pooled data from both studies. Polyphenon E 10% ointment was also significantly more effective than vehicle with regard to several secondary endpoints, including the complete clearance of baseline warts and partial clearance of at least 50% of all warts in both studies. Rates of recurrence of any warts or development of new warts were low (<9%) in both treatment arms during a 12-week follow-up period in both studies. Polyphenon E 10% ointment was generally well tolerated in adults with external genital and perianal warts. According to pooled data from the two clinical studies, the majority of adverse events associated with polyphenon E 10% ointment involved application site and local skin reactions at the treatment site.
Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail@adis.com
Sheridan M
SM
Hoy
D002392:Catechin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003218:Condylomata Acuminata / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007121:Immunocompetence; D008297:Male; D009824:Ointments; D016032:Randomized Controlled Trials as Topic
D009824:Ointments; D002392:Catechin; C472086:polyphenon E