None listed
Conditions
Interventions
Polyphenon E 10% ointment Type of group
Polyphenon E 10% ointment will be applied to genital warts.
Group name:placebo Type of group
Placebo of the Polyphenon E ointment will be applied to genital warts.
Sponsors
MediGene AG,
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Not contemplated. Measure:Not contemplated. Timepoints:Not contemplated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Not contemplated. Measure:Not contemplated. Timepoints:Not contemplated. | — |
Countries
Argentina, Chile, Colombia, Mexico, Peru, Romania, United States
Outcome results
None listed