"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of Veregen cream for women with vulval intraepithelial neoplasia (EPIVIN)
This trial is looking at Veregen cream to treat pre cancerous changes to the skin of the vulva.
Vulval intraepithelial neoplasia (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. There are 3 categories of VIN. This trial is for women with VIN 3, which means the cells are very abnormal. Your doctor may also call this severe dysplasia.
Doctors usually treat VIN 3 with surgery or occasionally with laser treatment. These treatments help but doctors are always looking for more treatments.
Veregen cream contains a substance that comes from green tea. We know from research that Veregen cream is safe to use and works for women with genital warts. The researchers think it may help women who have VIN 3. To find this out they want to compare Veregen cream with a dummy cream (
The aims of this trial are to find out
- If Veregen cream can help women with VIN
- How safe it is for women with VIN
- How it affects
quality of life
Who can enter
You may be able to join this trial if you have suspected VIN and you have been referred by your GP or
- Have vulval epithelial neoplasia 3 (VIN 3 or uVIN)
- Have 1 area of VIN that can be measured and is at least 10mm across
- Are willing to use reliable contraception, apart from condoms, during treatment if there is any chance you could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply
- You have had treatment for VIN in the past month
- You have or have been suspected of having cancer of the anus, cancer of the vagina or cancer of the vulva
- You have a severe problem with your liver or an ongoing problem with your liver
immune systemisn’t working very well
- You are taking medication that dampens down your immune system
- You are allergic to Veregen cream or its ingredients
- You are pregnant or trying to get pregnant
- You are breastfeeding
This is a phase 2 trial. The researchers need 56 women who are going to the City Hospital, Birmingham to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
- 28 women will use Veregen cream
- 28 women will use a dummy cream (
You use the cream 3 times a day for a maximum of 16 weeks. Your doctor or a specialist nurse will tell you how to apply the cream. You use your fingers to dab a small amount of it on the areas of VIN.
After 2 weeks a member of the research team will telephone you to see how you are managing with your treatment.
The trial team will ask you to fill out a questionnaire before you start treatment, at weeks 4 and 8 during treatment and after treatment at 4 months, 8 months and 1 year. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The researchers will ask for a small sample of tissue (
You see the doctor for a physical examination before agreeing to take part in this trial. During treatment you see your doctor at 1 month and 2 months. You see your doctor at the end of treatment and then about 8 months and a year after starting treatment.
The side effects of using Veregen cream mostly happen where it is applied. These include
- Sores or blisters
Your doctor will talk to you about all the possible side effects before you agree to take part in this trial.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor David Luesley
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
Sandwell and West Birmingham Hospitals NHS Trust
University of Birmingham