Sinecatechins, a Defined Green Tea Extract, in the Treatment of External Anogenital Warts: A Randomized Controlled Trial

    loading  Checking for direct PDF access through Ovid

Abstract

OBJECTIVE:

To estimate the clinical efficacy of topical sinecatechins, a defined green tea extract, in the treatment of external genital and perianal warts.

METHODS:

This was a randomized, double-blind, vehicle-controlled trial involving 502 male and female patients aged 18 years and older, with 2–30 anogenital warts ranging from 12 to 600 mm2 total wart area. Patients applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily for a maximum of 16 weeks or until complete clearance of all warts, followed by a 12-week treatment-free follow-up to assess recurrence.

RESULTS:

Complete clearance of all baseline and newly occurring warts was obtained in 57.2% and 56.3% of patients treated with sinecatechins ointment 15% and 10%, respectively, compared with 33.7% for vehicle (both P<.001). Significance was observed at weeks 4 and 6 and all subsequent visits. Numbers needed to treat were 4.3 and 4.4. Partial clearance rates of at least 50% were reported for 78.4% and 74.0% of patients in the sinecatechins ointment 15% and 10% groups compared with 51.5% of vehicle patients. During follow-up, recurrence of any wart was observed in 6.5%, 8.3%, and 8.8% in the sinecatechins ointment 15% group, sinecatechins ointment 10% group, and vehicle patients, respectively. A total of 3.7%, 8.3%, and 0.0% developed new warts, respectively. A total of 87.7% and 87.3% of patients in the sinecatechins ointment 15% and 10% groups, and 72.1% of vehicle patients experienced application site reactions; 49.2%, 46.2%, and 65.4% of those, respectively, were mild or moderate.

CONCLUSION:

Topical sinecatechins ointments 15% and 10% are effective and well-tolerated in the treatment of anogenital warts.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00449982

LEVEL OF EVIDENCE:

I

Related Topics

    loading  Loading Related Articles