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

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