Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

March 20, 2007 updated by: MediGene

A Randomized, Double-Blind, Three-Arm Parallel-Group, Placebo-Controlled Phase 3 Trial to Investigate the Clinical Efficacy and Safety of Polyphenon E in the Treatment of External Genital Warts

The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

External genital warts are non-malignant tumors caused by infections of the human papillomavirus (HPV), mainly types 6 and 11. Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves.

Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo

Study Type

Interventional

Enrollment

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
  • Chile
      • Santiago, Temuco, Chile
  • Colombia
      • Colombia, Bogota, Medellin, Risaralda, Colombia
  • Mexico
      • Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla, Mexico
  • Peru
      • Lima, Calao, Peru
  • Romania
      • Bucaresti, Brasov, Iasi, Cluj-Napoca, Romania
  • United States
    • California
      • Davis, San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • New York
      • New York, New York, United States
    • Oregon
      • Portland, Oregon, United States
    • Texas
      • Houston, Dallas, Austin, Texas, United States
    • Vermont
      • Burlington, Vermont, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >= 18 years at the time of enrollment
  • Clinical diagnosis of external genital warts (located genital, inguinal, perineal or perianal)
  • At least 2, but no more than 30 external genital warts
  • A total wart area between 12 and 600mm²
  • Negative pregnancy test and willingness to use effective contraception (for women of child-bearing potential)
  • For partners of male patients who are of child-bearing potential: use of effective contraception during the treatment period
  • Written informed consent
  • Ability to comply with the requirements of the study

Exclusion Criteria:

  • Participation in an investigational trail within 30 days prior to enrollment
  • Previous participation in a trial investigating Polyphenon E in the treatment of external genital warts
  • Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration
  • Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration
  • Systemic intake of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment and for the whole study duration
  • Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 month
  • Any current and/or recurrent pathologically relevant genital infections other than genital warts
  • Current known acute or chronic infection with HBV or HCV
  • Known HIV infection
  • Any current uncontrolled infection
  • Organ allograft
  • For female patients: pregnancy or lactation
  • Known allergies against any of the ingredients of the treatments
  • Any chronic or acute skin condition susceptible of interfering with the evaluation of the drug effect
  • Any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study
  • Internal (vaginal or rectal) warts requiring treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Complete clearance of all warts within a maximum of 16 weeks treatment
Severe local reaction during the treatment period

Secondary Outcome Measures

Outcome Measure
Time to complete clearance of all warts, of all baseline warts, and of all new warts
Partial clearance of warts at the end of treatment
Recurrence of any wart during the follow-up period
New warts during treatment and the follow-up period
Local sings and symptoms at the wart sites
Related adverse events during the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediGene

Investigators

  • Principal Investigator: Karl R. Beutner, M.D., Ph.D., Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2007

Last Update Submitted That Met QC Criteria

March 20, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 1018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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