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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediGene

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