Status:
COMPLETED
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
Lead Sponsor:
MediGene
Conditions:
Condylomata Acuminata
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00449982
Start Date
July 1 2003
End Date
August 1 2004
Last Update
March 21 2007
Active Locations (12)
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1
Davis, San Diego, California, United States
2
Denver, Colorado, United States
3
New York, New York, United States
4
Portland, Oregon, United States