A trial of two new treatments for vulval intraepithelial neoplasia (RT3 VIN)

Who can enter

You can enter this trial if you

• Have been diagnosed with VIN 3 in the last 3 months
• Have at least one area of VIN that is at least 20mm across and can be measured
• Are prepared to use reliable contraception while you are taking part in this trial
• Are at least 16 years old

You cannot enter this trial if you

• Have VIN 3 that extends into the opening of your back passage (your anus)
• Have had treatment for VIN in the last 4 weeks
• Have poor kidney function
• Have been diagnosed with vulval cancer, vaginal cancer or anal cancer
• Know you are allergic to cidofovir or imiquimod
• Have used cidofovir or imiquimod for a period of at least 3 months in the past, and it didn’t work
• Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 204 people into 2 groups. Group 1 will use cidofovir. Group 2 will use imiquimod.

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.

You apply the cidofovir gel or the imiquimod cream to the affected area of your vulva 3 times a week for 24 weeks at most (nearly 6 months). If the area of VIN completely goes away sooner than that, you can stop applying the treatment.

You will need to record when you apply the cream or gel on a treatment record card that the trial team will give you. You will also need to write down any painkillers you have taken.

If, at the end of the 24 weeks, the treatment hasn’t worked you may be able to swap to the other treatment. The trial doctors will discuss this with you.

If you agree to take part in this trial, the research team will ask you for 3 samples of your tissue (biopsies) and 3 blood samples. This is for a separate part of the trial called T-VIN. They take one before, one during and one after the course of treatment. You can still take part in the main trial if you don’t want to give samples for the T-VIN trial.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

• Physical examination
• Blood tests
• Urine test
• Biopsy (if you have not had one recently)
• Pregnancy test

You will see the doctors every 6 weeks while you are having treatment. You will have a urine test at each appointment. And the doctor will ask you about any side effects you are having.

You will have a biopsy, blood tests and a urine test about 6 weeks after you finish treatment. Depending on how well the treatment works, you will then see the doctor every 6 months for up to 2 years.

Side effects

As with all treatments, both cidofovir and imiquimod have side effects. The most common side effects of both treatments are

• Itching or burning
• Swelling
• Peeling or flaking
• Redness or ulceration
• Scabbing or crusting

Imiquimod can also cause skin weeping and erosion. And flu like symptoms such as headache and aching muscles.

Cidofovir can cause kidney problems when it enters the bloodstream. Because this trial uses cidofovir gel, it is unlikely that any of it would get into your bloodstream. But the trial team will check how well your kidneys are working while you are having treatment, just to be sure they are not affected.

It is important to remember that

• Everyone reacts differently to treatments
• You are not likely to get all these side effects
• While side effects can be moderate or severe, they are sometimes mild