NCT01082302

Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage

An Open-Label, Single-Center Phase I (Phase IV/ USA) Study to Assess the Pharmacokinetic Profile of Topically Applied Veregen® 15% in Patients With External Genital and Perianal Warts Compared With Oral Intake of a Green Tea Beverage

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: MediGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.

Conditions

• Genital Warts
• Perianal Warts

Interventions

Type	Name	Description
DRUG	Polyphenon E (Veregen) 15% ointment	3 times daily application on genital and perianal warts over 7 days
OTHER	Green Tea Beverage with defined catechin content	3 times daily oral intake over 7 days

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-03-08
• Last updated: 2010-09-08

Locations

1 site across 1 country: Germany