An integrated analysis of two randomized, double-blind, vehicle-controlled trials was conducted in 1,035 patients with external anogenital warts (EGWs) to determine the safety and efficacy of Polyphenon E® ointment (comprising green tea catechins). Polyphenon E® ointment 10% or 15% or vehicle was applied three times daily until complete clearance of all EGWs or up to 16 weeks. Complete clearance of EGWs occurred in 53.6, 54.9 and 35.4% of Polyphenon E® 10%, 15% and vehicle groups, respectively (P < 0.001 vs. placebo). Differences in clearance rates became significant versus placebo after 6 weeks of active treatment. There was a low recurrence rate across groups: 5.8, 6.8 and 6.5% in the Polyphenon E® ...