Introduction
Usual type vulvar intraepithelial neoplasia (uVIN), a putative precursor lesion of VSCC, is associated with persistent high-risk HPV (HR-HPV) infection; predominantly, the HPV16 strain.1,2 The condition primarily affects young women, with a peak age incidence of 30-49 years. In recent years, the incidence of VIN has increased by more than 3-fold.3,4 Although the malignant progression of uVIN is significantly lower than that of cervical intraepithelial neoplasia (CIN),5 typically of the order of 10%, unlike CIN, it often causes debilitating symptoms such as pruritus, pain and sexual dysfunction. To date, effective medical treatment is still lacking,6 and there is a compelling need for new medical treatments which could interrupt the natural history of uVIN.
VeregenĀ® ointment, with epigallocatechin-3-gallate (EGCG) as its primary bioactive green tea polyphenol, has been proved to be safe and effective in eradicating genital warts,7 a low-risk HPV-associated proliferative disorders. Here, we report findings from a Phase II randomised control feasibility study (EPIVIN) which evaluates the use of VeregenĀ® ointment in the treatment of women with uVIN, a hyperproliferative disorders caused by high-risk HPV infection.