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

Primary Purpose

Condylomata Acuminata

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Polyphenon E Ointment 10%, Polyphenon E Ointment 15%
Sponsored by
MediGene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Condylomata Acuminata focused on measuring Genital warts, Condylomata acuminata, Human Papillomavirus, Polyphenon E, Green tea extract, Vulva, Penis, Anus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2007
Last Updated
March 20, 2007
Sponsor
MediGene
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1. Study Identification

Unique Protocol Identification Number
NCT00449982
Brief Title
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MediGene

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condylomata Acuminata
Keywords
Genital warts, Condylomata acuminata, Human Papillomavirus, Polyphenon E, Green tea extract, Vulva, Penis, Anus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Polyphenon E Ointment 10%, Polyphenon E Ointment 15%
Primary Outcome Measure Information:
Title
Complete clearance of all warts within a maximum of 16 weeks treatment
Title
Severe local reaction during the treatment period
Secondary Outcome Measure Information:
Title
Time to complete clearance of all warts, of all baseline warts, and of all new warts
Title
Partial clearance of warts at the end of treatment
Title
Recurrence of any wart during the follow-up period
Title
New warts during treatment and the follow-up period
Title
Local sings and symptoms at the wart sites
Title
Related adverse events during the treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl R. Beutner, M.D., Ph.D.
Organizational Affiliation
Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA
Official's Role
Principal Investigator
Facility Information:
City
Davis, San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
New York
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Houston, Dallas, Austin
State/Province
Texas
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Buenos Aires
Country
Argentina
City
Santiago, Temuco
Country
Chile
City
Colombia, Bogota, Medellin, Risaralda
Country
Colombia
City
Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla
Country
Mexico
City
Lima, Calao
Country
Peru
City
Bucaresti, Brasov, Iasi, Cluj-Napoca
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
18515521
Citation
Tatti S, Swinehart JM, Thielert C, Tawfik H, Mescheder A, Beutner KR. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1371-9. doi: 10.1097/AOG.0b013e3181719b60.
Results Reference
derived

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

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