Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00449982
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : March 21, 2007
Sponsor:
Information provided by:
MediGene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Condylomata Acuminata Drug: Polyphenon E Ointment 10%, Polyphenon E Ointment 15% Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2003
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Warts Warts

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Complete clearance of all warts within a maximum of 16 weeks treatment
  2. Severe local reaction during the treatment period

Secondary Outcome Measures :
  1. Time to complete clearance of all warts, of all baseline warts, and of all new warts
  2. Partial clearance of warts at the end of treatment
  3. Recurrence of any wart during the follow-up period
  4. New warts during treatment and the follow-up period
  5. Local sings and symptoms at the wart sites
  6. Related adverse events during the treatment period

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449982


Locations
Layout table for location information
United States, California
Davis, San Diego, California, United States
United States, Colorado
Denver, Colorado, United States
United States, New York
New York, New York, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
Houston, Dallas, Austin, Texas, United States
United States, Vermont
Burlington, Vermont, United States
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
Sponsors and Collaborators
MediGene
Investigators
Layout table for investigator information
Principal Investigator: Karl R. Beutner, M.D., Ph.D. Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00449982    
Other Study ID Numbers: CT 1018
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 21, 2007
Last Verified: March 2007
Keywords provided by MediGene:
Genital warts
Condylomata acuminata
Human Papillomavirus
Polyphenon E
 Green tea extract
Vulva
Penis
Anus
Additional relevant MeSH terms:
Layout table for MeSH terms
Condylomata Acuminata
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Infections
Warts
Papillomavirus Infections
 DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases