A trial investigating the use of Veregen (EPIgallocatechin-3-gallate) in the treatment of Vulval Intraepithelial Neoplasia
- Conditions
- Topic: National Cancer Research NetworkCancerVulvar intraepithelial neoplasiaSubtopic: Gynaecological CancerDisease: Vulva
- Registration Number
- ISRCTN98495886
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33075197/ results (added 18/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 26
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome; Timepoint(s): 32 weeks
- Secondary Outcome Measures
Name Time Method Secondary outcome measures; Timepoint(s): 2, 4, 8, 16, 32 and 52 weeks