CompletedObservational

Developing a checklist to allow accurate diagnosis of vulval lichen sclerosus

Vulval lichen sclerosus is a long-term skin condition affecting the vulva (the skin outside the vagina). It can cause severe itching, pale patches, pain, and cracking of the skin. Because it can look like other conditions, many women wait months or years for a correct diagnosis. This study, funded by the National Institute for Health and Care Research (NIHR), is testing an expert checklist in NHS clinics. The aim is to give doctors and nurses a clear, reliable tool to spot the condition earlier. Women aged 18 and over who have recently been referred to a specialist clinic for a vulval issue may be able to join. Participation takes place during a single clinic visit and involves two separate skin examinations and optional photographs. By joining, participants help improve future care and speed up diagnosis for other women across the UK.

At a glance

Status

Completed

Sponsor

University of Nottingham

Enrolment target

407

Start

27 Sep 2024

Estimated completion

10 Aug 2026

Vulval lichen sclerosus

What is this study about?

Vulval lichen sclerosus is an inflammatory skin condition that affects the intimate skin around the opening of the vagina. It often causes persistent itching, soreness, thinning, and white patches on the skin. Without the right treatment, the delicate skin can tear, scar, or stick together, making everyday activities like sitting, walking, using the toilet, and having sex painful and distressing.

At present, there is no standard checklist to help doctors identify the condition. Because of this, it is frequently mistaken for common infections like thrush, and many women suffer in silence for a long time before receiving an accurate diagnosis. The earlier the condition is identified, the sooner effective treatments, such as steroid creams, can be started to prevent permanent damage.

To solve this problem, international skin experts have created a draft diagnostic checklist. This study, led by the University of Nottingham, aims to test how well the checklist works in real-world clinics. By comparing checklist results against expert specialist diagnoses, the research team hopes to prove that the tool works reliably for general healthcare professionals, including GPs.

Key takeaways

Tests a new checklist to help doctors diagnose vulval lichen sclerosus faster and more reliably.
Open to women aged 18 and older recently referred to a specialist clinic for a vulval skin issue.
Involves a single clinic appointment with two routine skin examinations.
Optional clinical photography; you can decline photos and still participate.
Does not involve any new medicines, and your standard NHS treatment will not be delayed.

Who may be eligible?

This study is open to women aged 18 and over who have recently been referred by their GP to a specialist skin clinic (in a hospital or community clinic) because of a vulval skin concern. To take part, your first appointment with the specialist clinic must have taken place within the last two weeks.

You will not be able to take part if you are unable to give informed consent for yourself. The study is also not suitable for people who have had surgical alteration of their vulval skin as part of gender reaffirming surgery, or people who were not born with a vulva, as these changes can affect how the skin appears during an examination.

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.

I am female and aged 18 or older.
I was referred by my GP to a specialist clinic for a vulval skin problem.
My initial specialist consultation was within the last two weeks.
I am able to read and understand the study information to give my consent.
I was born with a vulva and have not had gender reaffirming surgery on my vulval skin.

Answer every question to see your result.

What does participation involve?

Taking part in this study involves attending a single research appointment, which is usually arranged around your normal clinic visit. There are no experimental medications or changes to your prescribed treatment.

During this visit, you will have two brief physical examinations of your vulval area. The first examination is carried out by your regular specialist doctor. The second examination is carried out by an independent healthcare professional who will use the new checklist without knowing what the first doctor diagnosed. You will also be asked if you are happy to have clinical photographs taken of the affected skin, but this is entirely optional. Once the appointment is finished, your participation is complete, and your usual medical care continues as normal.

Potential risks and benefits

Taking part will not directly cure your condition, but it could help doctors diagnose other women much sooner in the future, avoiding unnecessary pain and delays. There are no major physical risks associated with taking part, as the study does not involve new drugs or invasive procedures. An intimate examination can sometimes feel uncomfortable or embarrassing, but staff are experienced and will do everything to ensure your dignity and comfort. You are entirely free to withdraw from the study at any point without giving a reason, and doing so will never affect the standard of NHS care you receive.

Locations (19)

Manchester University NHS Foundation Trust
City only
Manchester, England
Salford Royal
Approximate
Salford, England
Grampian
Approximate
Aberdeen, Scotland
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
City only
Nottingham, England
James Cook University Hospital
Approximate
Middlesbrough, England
Torbay and South Devon NHS Foundation Trust
Unverified
Torquay, England
Sunderland Royal Hospital
Unverified
Sunderland, England
Southampton University Hospital
Unverified
Southampton, England
County Durham and Darlington NHS Foundation Trust
Unverified
Darlington, England
Royal Devon University Healthcare NHS Foundation Trust
Unverified
Exeter, England
Ninewells Hospital
Unverified
Dundee, Scotland
Princess of Wales Hospital
Unverified
Bridgend, Wales

Common questions

Will taking part change the treatment I receive?

No. Taking part will not alter your normal NHS medical care. Your specialist will still recommend the standard treatments best suited to your condition.

Do I have to agree to have photographs taken?

No. Having clinical photographs taken is completely optional. You can still take part in the main study even if you prefer not to have any photos taken.

Will the examinations be painful?

The examinations are visual checks similar to standard routine skin assessments. While the skin may already feel tender, the doctors will be gentle and you can ask to stop at any time.

How long will the study take for me?

Your participation is completed in a single clinic visit. There are no ongoing follow-up visits or long-term diary requirements.

Who is funding and running this research?

The study is run by the University of Nottingham and funded by the National Institute for Health and Care Research (NIHR), the research partner of the NHS.

How to find out more

Rheanne Leatherland

shells@nottingham.ac.uk None provided Official trial record

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