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.