Polyphenon E 10% ointment: a guide to its use in the treatment of external genital and perianal warts
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Polyphenon E 10% ointment: a guide to its use in the treatment of external genital and perianal warts Katherine A. Lyseng-Williamson and Sheridan M. Hoy Adis, Auckland, New Zealand
Polyphenon E 10% ointment (Veregen), which contains a mixture of green tea catechins, is indicated for the treatment of external genital and perianal warts in immunocompetent adults. Application of polyphenon E 10% ointment for up to 16 weeks was significantly more effective than vehicle in clearing external genital and perianal warts. Local skin reactions at the wart treatment site are very common and are related to the mode of action of the ointment.
What is the rationale for developing the drug? External genital and perianal warts (Condylomata acuminata) result from the sexual transmission of human papillomaviruses (HPV), primarily HPV genotypes 6 and 11.[1-3] HPV genotypes 16 and 18 are primarily responsible for carcinomas of the anus, cervix, vagina and vulva. Although external genital and perianal warts are often asymptomatic, they may be painful or pruritic, and have a negative impact on health-related quality of life.[1,2,4] Patients with these types of warts may experience spontaneous HPV clearance and disease regression, but most patients prefer to undergo treatment to clear the warts.[5] The selection of appropriate patient-applied or healthcare provider-administered treatment is influenced by multiple factors, including the anatomical location, morphology, number and size of the warts.[5,6] Warts located on moist (partly keratinized) surfaces and intertriginous areas (e.g. the vulva) appear to respond more effectively to topical therapy than warts on dry (fully keratinized) surfaces and open areas (e.g. the penile shaft).[6] Historically, chemical destruction, immunological therapy and/or surgical procedures have been used to treat external genital and perianal warts; however, such measures often result in scarring and are associated with high recurrence rates.[1] Although quadrivalent HPV vaccines are now available to offer protection against both genital cancers and genital warts,[3,7] there is still a need for new and effective treatments. Topical patient-applied ointments containing polyphenon E (Veregen) at concentrations of 10% (Europe)[8] or 15% (US)[9] have been developed for the treatment of Drugs Ther Perspect 2012; Vol. 28, No. 11
external genital and perianal warts in adults. Polyphenon E is a proprietary botanical extract containing a mixture of catechins extracted from green tea leaf. This article focuses on the clinical use of polyphenon E 10% ointment as approved in European countries.[8]
How does the drug work? Polyphenon E 10% ointment acts locally to clear external genital and perianal warts.[8] Although their exact mechanism in the clearance of external genital and perianal warts is not fully understood, green tea catechins have been shown to have antiviral, immunostimulatory, antiproliferative and antitumour properties.[1,10,11] In preclinical studies, polyphenon E inhibited the growth of activated
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