Topical Polyphenon®E in the treatment of external genital and perianal warts: a randomized controlled trial

Abstract

Benign external genital and perianal warts (condylomata acuminata) are disfiguring, displeasing skin tumours caused by human papillomavirus that may vitally burden affected patients and their partners. Current treatment options are still unsatisfactory due to low efficacy, high recurrence rates or an unfavourable side-effect profile. Although most recently prophylactic vaccines have been recommended for adolescent women, appropriate treatment modalities for anogenital warts are still needed. Green tea catechins exert antiviral, antioxidative, antiproliferative and immunostimulatory activity. Polyphenon E (MediGene AG, Munich, Germany), a proprietary extract of green tea leaves, was therefore investigated for the topical treatment of this frequent viral disease. To investigate Polyphenon E 15% and 10% ointment for efficacy and safety in the treatment of anogenital warts in immunocompetent men and women. Five hundred and three patients were randomized to receive either Polyphenon E 15% or 10% ointment or matching vehicle. The topical treatment was self-applied by the patients three times daily to all warts. Assessment of response and of adverse events was performed biweekly until complete clearance of all (baseline and new) anogenital warts or for up to 16 weeks. Recurrence was evaluated during a 12-week treatment-free follow-up period for patients with complete clearance. About 53% of patients treated with Polyphenon E 15% ointment showed complete clearance of all baseline and new anogenital warts, 51% for Polyphenon E 10% ointment, and 37% for vehicle (P = 0.01 and P = 0.03, respectively; two-sided Fisher's exact test; intent-to-treat population, last observation carried forward analysis). Women responded better than men, with about 60% of women and 45% of men in both active groups achieving complete clearance of all warts. Time to complete clearance was comparable for both strengths of Polyphenon E ointment. About 78% of all patients treated with either Polyphenon E 15% or 10% ointment showed wart clearance rates of 50% or better. Less than 6% and 4% of patients in the Polyphenon E 15% and 10% ointment groups experienced wart recurrence during follow-up. Polyphenon E ointments demonstrated a good safety profile with the majority of all adverse events being local application site reactions assessed as mild or moderate. Local reactions declined during continued treatment. The results indicate that Polyphenon E ointment is an efficacious and safe patient-applied topical treatment for external genital and perianal warts. Its use in intra-anal, intravaginal and cervical condylomas and other intraepithelial lesions warrants further clinical investigation.