A trial of Veregen cream for women with vulval intraepithelial neoplasia (EPIVIN)

Cancer type:

Vulval cancer

Status:

Results

Phase:

Phase 2

This trial was 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 was for women with VIN 3, which means the cells are very abnormal. Your doctor may also call this severe dysplasia.

This trial was open for people to join between 2014 and 2017. The team published the results in 2020.

More about this trial

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 thought it may help women who have VIN 3. To find this out they wanted to compare Veregen cream with a dummy cream (placebo Open a glossary item).
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 Open a glossary item

Summary of results

The team found that Veregen cream was safe and did work to reduce the VIN and its symptoms.

About this trial
This was a phase 2 trial. 26 women took part. It was a randomised double blinded trial. Neither the women nor their doctor chose which group they were in. They also didn’t know which cream they used. 

There were 2 groups:

  • 13 women used Veregen cream
  • 13 women used a dummy cream (placebo)

Everyone was told to use their cream 3 times a day for 16 weeks. After starting treatment the trial team followed them up at:

  • 2 weeks
  • 1 month
  • 2 months
  • 4 months
  • 8 months
  • 1 year

Results
Of the 26 women, 19 women used the cream for 16 weeks. 9 used the Veregen cream and 10 used the dummy cream. 

The trial team collected the information from these 26 women to produce the results. 

At 4 months and 8 months the trial team took a sample of tissue (biopsy). They looked to see if the VIN was still in the sample or if it had become cancer. There were no differences in the biopsies between the two groups. 

Everyone had an appointment with their doctor at 4 months and 8 months. The doctor examined them and reported whether the VIN was present, had gone or got worse. 

At 4 months
For the women who used Veregen cream their doctor reported:

  • no sign of VIN in 5 women 
  • an improvement in 5 women but there was still some VIN present
  • no change in 2 women

The trial team couldn’t report on 1 woman because she was lost to follow up. 

For women who used the dummy cream their doctor reported:

  • no sign of VIN in 2 women
  • an improvement in 3 women with some VIN still present
  • no change in 4 women
  • the VIN got worse in 1 woman

The team couldn’t report on 2 women because they were lost to follow up. 

At 8 months

For 1 woman in the Veregen group who had an improvement at 4 months their VIN was worse at 8 months.

In the group who used the dummy cream the VIN got worse in 2 women at 8 months. In one of these women there had been no sign of VIN at 4 months. Another 2 women had no sign of VIN at 8 months and the remaining group had no change in their VIN.

Quality of life and symptoms of pain
The trial team looked at the quality of life and symptoms of pain in the group who used the dummy cream. They found there was no difference from before the women started using the cream to one year later. For the women using Vergen both quality of life and symptoms of pain were reported as being lower after 4 months. These generally remained unchanged at 8 months. 

Side effects
Women in both groups reported some local irritation. But this was present before they had started treatment. 

 Overall most side effects reported were very mild. For women who used the dummy cream 89 out of every 100  (89%)  had side effects. For women who used Veregen it was 74 out of every 100 (74%) who reported side effects.

Only 2 women who used Vegren reported more severe side effects. One reported having a skin rash and the other had a burning sensation. 

One woman who used the dummy cream reported no side effects at all. 

All side effects went once the women had stopped using the creams. 

Conclusion
The trial team concluded that Veregen cream:

  • was safe to use
  • did reduce VIN
  • could possibly improve quality of life

These results suggest that a larger phase 3 clinical trial using Veregen cream should take place. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor David Luesley

Supported by

NIHR Clinical Research Network: Cancer
University of Birmingham
Sandwell and West Birmingham Hospitals NHS Trust
NIHR Research for Patient Benefit (RfPB) Programme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11782

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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