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

Completed · Phase 3

Conditions studied: Condylomata Acuminata

In brief

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.

Key facts

Study ID

NCT00449982

Run by

MediGene

People needed

480

Starts

2003-07-01

Expected to finish

2004-08-01

Last updated by the study team

2007-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Davis, San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — New York, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Houston, Dallas, Austin, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Buenos Aires, Argentina
• Study site — Santiago, Temuco, Chile
• Study site — Colombia, Bogota, Medellin, Risaralda, Colombia
• Study site — Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla, Mexico
• Study site — Lima, Calao, Peru
• Study site — Bucaresti, Brasov, Iasi, Cluj-Napoca, Romania

Full record on ClinicalTrials.gov

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