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Sponsored by: |
MediGene |
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Information provided by: | MediGene |
ClinicalTrials.gov Identifier: | NCT00449982 |
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.
Condition | Intervention | Phase |
---|---|---|
Condylomata Acuminata |
Drug: Polyphenon E Ointment 10%, Polyphenon E Ointment 15% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 480 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | August 2004 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Davis, San Diego, California, United States | |
United States, Colorado | |
Denver, Colorado, United States | |
United States, New York | |
New York, New York, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, Texas | |
Houston, Dallas, Austin, Texas, United States | |
United States, Vermont | |
Burlington, Vermont, United States | |
Argentina | |
Buenos Aires, Argentina | |
Chile | |
Santiago, Temuco, Chile | |
Colombia | |
Colombia, Bogota, Medellin, Risaralda, Colombia | |
Mexico | |
Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla, Mexico | |
Peru | |
Lima, Calao, Peru | |
Romania | |
Bucaresti, Brasov, Iasi, Cluj-Napoca, Romania |
Principal Investigator: | Karl R. Beutner, M.D., Ph.D. | Solano Clinical Research, 635 Anderson Road #17, Davis CA 95616, USA |
Study ID Numbers: | CT 1018 |
Study First Received: | March 20, 2007 |
Last Updated: | March 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00449982 |
Health Authority: | United States: Food and Drug Administration |
Genital warts Condylomata acuminata Human Papillomavirus Polyphenon E |
Green tea extract Vulva Penis Anus |
Virus Diseases Skin Diseases, Infectious Sexually Transmitted Diseases, Viral Warts Skin Diseases Condyloma acuminatum |
Condylomata Acuminata Sexually Transmitted Diseases Condyloma DNA Virus Infections Papillomavirus Infections |
Skin Diseases, Viral Tumor Virus Infections |