Topic: National Cancer Research Network
Conditions
Interventions
1. Experimental arm, Veregen 10%
2. Placebo
Study Entry: Single Randomisation only
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease 2. Pregnant, breastfeeding or trying to conceive 3. Treated for VIN within the previous four weeks 4. Known allergy to Veregen or any of its components 5. Patients suffering from immunosuppressive disorder or taking immunosuppressives 6. Unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome; Timepoint(s): 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures; Timepoint(s): 2, 4, 8, 16, 32 and 52 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed