Abstract 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 Source:

J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12. PMID: 17958849

Abstract Author(s):

G Gross, K-G Meyer, H Pres, C Thielert, H Tawfik, A Mescheder

Abstract:

OBJECTIVE: Clinical efficacy and safety of Polyphenon(R) E, a defined green tea extract, in external genital warts. DESIGN: Randomized, double-blind, placebo-controlled study for up to 12 weeks with a 12-week treatment-free follow-up. SETTING: Twenty-eight hospitals and practices in Germany and Russia. PATIENTS: 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. MAIN OUTCOME MEASURE(S): 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.

Study Type : Human Study
Additional Links

Print Options


Key Research Topics

Sayer Ji
Founder of GreenMedInfo.com

Subscribe to our informative Newsletter & get Nature's Evidence-Based Pharmacy

Our newsletter serves 500,000 with essential news, research & healthy tips, daily.

Download Now

500+ pages of Natural Medicine Alternatives and Information.

This website is for information purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional.

© Copyright 2008-2020 GreenMedInfo.com, Journal Articles copyright of original owners, MeSH copyright NLM.