Pharmacodynamics

The mode of action of Veregen™ Ointment, 15% involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.

Pharmacokinetics

The pharmacokinetics of topically applied Veregen™ Ointment has not been sufficiently characterized at this time. However, data suggest that systemic exposure to catechins after repeated topical application of Veregen™ Ointment 15% is likely to be less than observed after a single oral intake of 400ml green tea.

Clinical Studies

Two Phase 3 randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen™ Ointment in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both studies the median baseline wart area was 51 mm² (range 12 to 585 mm²), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.

Table 1: Efficacy by Region

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen™ and 5.8% (4/69) for those treated with vehicle.

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