Strengths and Limitations
The main strength of our study lies in the fact that our study was
randomised double-blind controlled in nature and all histological
assessments were reviewed and reported centrally by an accredited
pathologist specialising in gynaecological oncology. Due to funding
constraints and the rarity of the disease, we were not able to achieve
our intended recruitment target in time and in a single centre setting.
Furthermore, as a tertiary referral central, which manages complex
pre-malignant and malignant vulval disease, our patient cohort comprised
mainly of those who have a refractory disease with previous multiple
treatment failure. Hence, there was lack of patients with primary uVIN
in our cohort. Nevertheless, we were able to demonstrate that VeregenĀ®
treatment led to clinical improvements both objectively, through a
reduction in lesion size and subjectively through patients QoL and
symptoms assessment.