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Spots Global Cancer Trial Database for Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

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Trial Identification

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

Official Title: 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

Study ID: NCT00449982

Study Description

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 male and female patients.

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 of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves. Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Davis, San Diego, California, United States

, Denver, Colorado, United States

, New York, New York, United States

, Portland, Oregon, United States

, Houston, Dallas, Austin, Texas, United States

, Burlington, Vermont, United States

, Buenos Aires, , Argentina

, Santiago, Temuco, , Chile

, Colombia, Bogota, Medellin, Risaralda, , Colombia

, Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla, , Mexico

, Lima, Calao, , Peru

, Bucaresti, Brasov, Iasi, Cluj-Napoca, , Romania

Contact Details

Name: Karl R. Beutner, M.D., Ph.D.

Affiliation: Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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