EPIVIN LogoPhase II clinical trial investigating the use of epigallocatechin-3-gallate (Veregen) in the treatment of vulval intraepithelial neoplasia.

Trial Overview and Summary

Chief Investigator: Professor David Luesley
Sponsor: Co-sponsorship between University of Birmingham and Sandwell and West Birmingham Hospital (SWBH) Trust
Funders: NIHR - Research for patient benefit (RfPB)
Disease Site: Vulva (Gynaecology)
Trial Type: Clinical Trial of an Investigational Medicinal Product 
Status: Open
UKCRN Study ID: (if applicable)  
ISRCTN Reference Number: ISRCTN15094808
Open to new sites? Not at Present
Recruitment start date: 18th September 2014
Anticipated Recruitment end date 11th October 2017
CRCTU Trial Management Team: Late Phase Trial Management Team - A
Trial E-mail Address: EPIVIN@trials.bham.ac.uk

Trial Summary

  • View Trial Summary Document [.pdf]

This trial is looking at Veregen cream to treat Vulval intraepithelial neoplasia (VIN). VIN means there are pre-cancerous changes to cells in the skin of the vulva. It is not cancer, but if it isn’t treated it can develop into vulval cancer. This trial is for women with VIN3, which means the cells are very abnormal.

Veregen cream contains a substance that comes from green tea. To find out if it can help women with VIN3, researchers want to compare Veregen cream with a dummy cream.

The main aim of this trial is to find out if Veregen cream is a safe and effective treatment for VIN3 patients.

 Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Protocol

Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website (see the link below).

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

  • View Trial Protocol Document [.pdf]

More Information