Active not recruitingOBSERVATIONAL

Clinical and Molecular Correlates of Response to First Line Treatment in Lichen Planus

Lichen Planus can cause discomfort and affects areas like the mouth, skin, and genitals. While steroid creams help manage symptoms for many, they don't cure the condition and aren't always effective for everyone. This study aims to understand why some patients don't respond well to their first-line steroid treatment by looking at various factors. Researchers will consider things like a person’s age, general health, smoking and drinking habits, as well as examining germs (bacteria) in the mouth and how the body’s immune system reacts. The goal is to find better ways to diagnose Lichen Planus, predict how it might progress, and eventually develop more personalised and effective treatments.

At a glance

Status

Active not recruiting

Sponsor

University of Aberdeen

Enrolment target

110

Start

07 Feb 2022

Estimated completion

30 Sep 2026

Lichen Planus, Oral Lichen Planus of Vulva

What is this study about?

Lichen Planus is a common condition that can cause discomfort and soreness, mainly in the mouth, but also on the skin and in intimate areas like the vulva. It can make everyday activities like eating or talking difficult and can impact your quality of life. For some types of Lichen Planus, there's even a slightly higher risk of certain cancers, so getting treatment is really important to manage symptoms and improve how you feel.

The usual first treatment for Lichen Planus is to apply steroid creams or gels directly to the affected areas. While these treatments are good at controlling the symptoms, they don't actually cure the condition. Also, they don't work for everyone, and we don't fully understand why. It might be due to individual differences, the types of bacteria in the mouth, or how each person's body reacts.

This study wants to get to the bottom of why these common treatments don’t always work. Researchers will look at different things like your age, other health conditions, and lifestyle habits such as smoking or drinking. They'll also analyse samples to understand the tiny germs (microbes) in your mouth and how your body’s immune system is responding. By doing this, they hope to identify specific factors linked to poor treatment response. This knowledge is crucial because it can help doctors diagnose the condition better, predict how it might progress, and pave the way for developing brand new, more tailored treatments that work better for each individual.

Key takeaways

Lichen Planus causes soreness, mainly in the mouth.
First-line steroid treatments don't always work for everyone.
This study aims to find out why treatment responses vary.
Researchers will examine clinical factors and mouth bacteria.
No new medicines will be given as part of this study.
The goal is to improve diagnosis and develop better, tailored treatments.

Who may be eligible?

To be able to take part in this study, you generally need to be over 18 years old and have a confirmed diagnosis of Lichen Planus that affects your mouth, or both your mouth and vulva. This diagnosis must have been confirmed by a small tissue sample (biopsy). You also need to be currently using steroid creams or gels as part of your treatment plan for Lichen Planus, and be able to give your consent to participate.

There are some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you wouldn't be eligible. Also, if you are currently taking stronger steroid tablets or other medicines that affect your immune system for Lichen Planus, or if your condition is actually a different inflammatory illness that looks similar to Lichen Planus, you wouldn't be able to take part.

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 over 18 years old?
Do you have a confirmed diagnosis of Lichen Planus (oral or oral and vulvovaginal)?
Are you currently using topical steroid treatment for your Lichen Planus?
Are you able to agree to take part and attend an initial and follow-up appointment?
Are you NOT pregnant or breastfeeding?
Are you NOT taking stronger steroid tablets or other immune-suppressing medicines for Lichen Planus?

Answer every question to see your result.

What does participation involve?

This study does not involve giving you any new medicines or treatments. Instead, if you decide to take part, the researchers will gather information from your existing medical and dental records once you've given your permission. They will look at details about your age, general health, and habits like smoking or drinking. They might also take samples, such as from your mouth, to understand the bacteria there and how your immune system is working. You would need to attend an initial appointment and a follow-up appointment after your treatment, which will be part of your usual care. The overall duration of your involvement will depend on your treatment plan and these two appointments.

Potential risks and benefits

This study involves little to no direct risk to you, as no new treatments are being given. However, you might experience minor discomfort if any samples, like those from your mouth, are taken, though these are routine and generally well-tolerated. The potential benefit for you is that by contributing your information, you are helping doctors and scientists understand Lichen Planus better. This could lead to improved diagnosis and more effective, personalised treatments for future patients, and potentially for you too. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (2)

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

University of Aberdeen
Verified postcode
Aberdeen, United Kingdom
Aberdeen Dental School
Verified postcode
Aberdeen, United Kingdom

Common questions

What is Lichen Planus?

It's a common condition causing sore patches, mostly in the mouth, but also on the skin and in genital areas.

Will I get new medicine in this study?

No, this study only looks at why current treatments (steroid creams) work differently for people; you won't be given new medicines.

What information will the researchers collect?

They'll look at things like your age, general health, lifestyle, and take samples to study mouth bacteria and your body's immune response.

Why is this study important?

It aims to understand why existing treatments don't always work, helping to find better ways to diagnose and treat Lichen Planus in the future.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, and this will not affect your medical care.