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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Condylomata Acuminata

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Complete clearance of all warts within a maximum of 16 weeks treatment

Principal Investigator

Karl R. Beutner, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA

Authority:

United States: Food and Drug Administration

Study ID:

CT 1018

NCT ID:

NCT00449982

Start Date:

July 2003

Completion Date:

August 2004

Related Keywords:

  • Condylomata Acuminata
  • Genital warts
  • Condylomata acuminata
  • Human Papillomavirus
  • Polyphenon E
  • Green tea extract
  • Vulva
  • Penis
  • Anus
  • Condylomata Acuminata

Name

Location

Fountain Valley, California  92708
Albany, New York  12208
Austin, Texas  78705
Denver, Colorado  
Eugene, Oregon  
South Burlington, Vermont