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

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.

• Authors: G Gross, K-G Meyer, H Pres, C Thielert, H Tawfik, A Mescheder
• Journal: Journal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 21 Issue 10 Pg. 1404-12 (Nov 2007) ISSN: 0926-9959 [Print] England
• PMID: 17958849 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Ointments
• Placebos
• Catechin
• polyphenon E

Topics

• Adolescent
• Adult
• Aged
• Catechin (analogs & derivatives, chemistry, therapeutic use)
• Condylomata Acuminata (drug therapy)
• Double-Blind Method
• Female
• Humans
• Logistic Models
• Male
• Middle Aged
• Ointments
• Placebos
• Prognosis
• Statistics, Nonparametric
• Treatment Outcome