MedTrace Logo

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

NCT01082302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2010-09-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Charité Research Organisation GmbH

    collaborator OTHER

  • MediGene

    lead INDUSTRY

Principal Investigators

  • Frank Wagner, Md, PD · Charité Research Organisation, Berlin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01082302 on ClinicalTrials.gov