A trial investigating the use of Veregen (EPIgallocatechin-3-gallate) in the treatment of Vulval Intraepithelial Neoplasia

INTERVENTION: 1. Experimental arm, Veregen 10% 2. Placebo Study Entry: Single Randomisation only CONDITION: Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Vulva ; Cancer ; Vulvar intraepithelial neoplasia PRIMARY OUTCOME: Primary Outcome; Timepoint(s): 32 weeks SECONDARY OUTCOME: Secondary outcome measures; Timepoint(s): 2, 4, 8, 16, 32 and 52 weeks INCLUSION CRITERIA: 1. Female = 18 years of age 2. Histological confirmation of 'usual' type vulval intraepithelial neoplasia (VIN3)* 3. At least one lesion that can be accurately measured (using the RECIST 1.1 criteria) in at least one dimension with longest diameter = 20 mm 4. Using a reliable method of contraception (excluding condoms) 5. Written informed consent to participate in the trial * All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology, 10% of biopsies will be independently reviewed by a second pathologist