RecruitingInterventional

A feasibility study to evaluate platelet-rich plasma and autologous lipotransfer to treat vulval fibrosis in lichen sclerosus

This study is exploring potential new treatments for vulval lichen sclerosus (VLS), a skin condition affecting the area around the vagina. VLS can cause itching, pain, and scarring, making everyday activities difficult. While steroid creams are the usual treatment, some people still experience ongoing problems and scarring. This research will compare two newer treatments – using the patient's own fat (fat grafting) or a special part of their blood (platelet-rich plasma) – against the usual steroid cream. The aim is to see if these new approaches are acceptable, safe, and show promise for improving symptoms and scarring. This is a small, initial study to help plan a larger one in the future, ultimately hoping to find more effective ways to help people with VLS.

At a glance

Status

Recruiting

Sponsor

Royal Free London NHS Foundation Trust

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Nov 2026

Treatment of vulval fibrosis in vulval lichen sclerosus

What is this study about?

Imagine your skin has a condition called lichen sclerosus, which mainly affects the sensitive skin around the entrance to the vagina (the vulva). Sometimes, this condition can cause the skin to become very itchy, sore, and scarred, which can make things like sex or even simply going to the toilet uncomfortable and difficult. While steroid creams often help, some people still struggle with scarring and ongoing symptoms.

This study wants to explore if two newer types of treatment could be helpful. One treatment involves taking a small amount of fat from your own body and injecting it into the vulva, which is called 'fat grafting'. The other treatment involves taking some of your blood, preparing it specially to get something called 'platelet-rich plasma' (PRP), and then injecting that into the vulva. These treatments have shown some promise in earlier studies, and researchers want to see if they can help with the scarring and discomfort from lichen sclerosus.

This particular study is a 'feasibility study', which means it's a small, early step to find out if these new treatments are practical and if it's possible to properly measure how well they work. It will also help the researchers decide if a much bigger study, involving more hospitals and people, should be done in the future. The ultimate goal is to find better ways to treat vulval lichen sclerosus and improve the lives of those affected.

Key takeaways

This study explores new treatments for scarring in vulval lichen sclerosus (VLS).
It compares fat grafting and platelet-rich plasma with standard cream treatment.
The aim is to check if these new treatments are acceptable and how well they work.
It will help researchers decide if a larger study is needed in the future.
Participation involves questionnaires, photos, and skin measurements over six months.
Patients in the control group will be offered a new treatment after the study ends.

Who may be eligible?

This study is looking for women aged 18 or older who live in the UK and have been diagnosed with vulval lichen sclerosus by a specialist. It's important that your condition has caused some changes and scarring in the vulval area.

However, there are some reasons why you wouldn't be able to join. For example, if you've recently had cancer or certain precancerous changes in the vulva, or if you've already had the fat grafting or PRP treatment for this condition before. Also, if you're pregnant, breastfeeding, or planning to get pregnant during the study, you can't take part. There are also restrictions based on your weight (BMI), if you have certain other medical conditions affecting the vulva or your immune system, or if you can't have a general anaesthetic.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female and aged 18 or over?
Have you been diagnosed with vulval lichen sclerosus by a specialist?
Has your condition caused some scarring or changes to the vulval area?
Do you live in the UK and speak English?
Are you NOT pregnant, breastfeeding, or planning to be during the study?
Have you NOT had fat grafting or PRP for VLS before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of up to 75 women in the study. You will be randomly assigned to one of three groups: one group will receive fat grafting, another will receive platelet-rich plasma (PRP), and the third group will continue with steroid cream only. If you are in one of the surgical groups (fat grafting or PRP), you will have one operation. Everyone in the study will continue using their usual steroid cream.

Throughout the study, you'll fill out questionnaires about your symptoms, how the condition affects your daily life, and your sexual health. The research team will also take pictures of your vulva and measure skin thickness with special equipment to see if there are any improvements. You'll be followed up for six months after the treatment or after you join the study. If you're in the 'steroid cream only' group, you'll be offered one of the new surgical treatments at the end of the study.

Potential risks and benefits

If you are in one of the new treatment groups (fat grafting or PRP), there's a chance these treatments might help improve your lichen sclerosus symptoms and scarring. If you're in the group that only uses steroid cream, you'll be offered one of the new surgical treatments once the study finishes. This study is an important first step; if these new treatments are found to be effective, they could become new options for many people in the future. All surgical procedures carry some risks, and will be performed under general anaesthetic. A specialist will check if anaesthesia is safe for you. Common, minor side effects of the new treatments include bruising, tenderness, and swelling in the treated area. You can withdraw from the study at any time.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Free London NHS Foundation Trust
City only
London, United Kingdom
Nottingham University Hospitals NHS Trust - City Campus
City only
Nottingham, United Kingdom

Common questions

What is vulval lichen sclerosus?

It's a lasting skin condition that mainly affects the skin around the entrance to the vagina (the vulva), causing itching, pain, and sometimes scarring.

What are the new treatments being tested?

The study is looking at injecting your own fat (fat grafting) or a special part of your blood (platelet-rich plasma – PRP) into the vulva.

Will I still use my steroid cream?

Yes, all participants in the study will continue to use their prescribed steroid cream.

Where will the study take place?

The main centre is Royal Free Hospital in London, with some procedures also at Hadley Wood. Nottingham University Hospital is also helping find participants.

How long will I be involved in the study?

You will be followed up for six months after your treatment or joining the study.

How to find out more

Sara Jasionowska

s.jasionowska@nhs.net +44 20 7443 9757 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.