The information here is to help you understand why the research is being carried out and what it will involve for you if you decide to take part. Please ask us if you would like to have more information, or if there is anything that is unclear to you.
Watch this short video about PEARLS study:
Lichen sclerosus (LS) is an itchy and distressing condition affecting vulval skin (the skin around the outside of the vagina). It can lead to scarring if it is not treated. Scarring can cause the labia minora (inner lips) to fuse together or the entrance to the vagina to narrow. LS affects around 1 million women in the UK. People with LS are at higher risk of developing vulval cancer. Vulval LS can affect children and women of any age, but it is more common in women who have gone through the menopause and children before puberty. It is a long-term condition that needs ongoing treatment to manage flares of symptoms. LS flares are usually treated with steroid creams to get control of the symptoms.
What are we trying to find out?
We do not know the best way to manage future flares of LS. Some people think that using steroid cream in between flares, even when there are no symptoms, may reduce symptoms overall. We want to study if using a steroid treatment regularly (e.g. twice a week), even when symptoms are controlled, is better than using steroid cream only during a flare.
This study will enrol 400 women and randomly allocate half to use their steroid cream twice a week, and half to only use it if they experience symptoms (i.e. a flare). We will compare how many people in each group experience a LS flare. We will use photographs taken at the start to see if scarring has worsened during the study. Any patient aged 5 and over with vulval LS will be able to enter the study, regardless of ethnicity or background. We will follow patients for two years to gather data to answer our questions. We will also ask for permission from patients to check their medical records for a number of years after the study. This will help us to see how many patients in each treatment group get cancer. We will interview patients to explore how they feel about the study and the different ways of treating LS that we are testing. We will also compare the costs and outcomes of the two treatments used in the study to see if one is better value for money for the NHS.
It is important to understand the best way to treat LS to reduce the long-term impact of the condition. If one treatment is better, patients in the future can be advised how best to manage their condition. Avoiding flares of LS and reducing scarring will improve the quality of life of patients and reduce need for treatments and support.
How will we involve patients and the public?
Two patient representatives are part of the study team. They are both women with LS. They have been involved in designing the study. We conducted an online survey involving 393 people with LS to inform the design of our study. Our patient representatives will continue to advise on the study as it progresses. We have also formed an advisory panel of women with LS and parents of girls with LS. This panel was consulted during the development process and will continue to contribute during the course of the study.
How will the results of the trial be shared?
The results of this study will be used to write clinical guidelines that doctors and patients will use to make decisions about their treatment. Everyone who takes part in the study will be sent the study results. We will also share them with patients via patient groups and social media, such as the UK LS support group on Facebook. The results will be written up in academic journals and shared at conferences.
If you live in East Midlands or North West, and are willing to travel to the sites in Nottingham or Liverpool, have been diagnosed with lichen sclerosus and think that you might be eligible, please complete a short form. Your details will be picked up by a member of the team who will contact you to discuss your involvement. Alternatively, get in touch with the trial central team by email: PEARLS@nottingham.ac.uk or telephone: 0115 8231609/SKYPE 01157485961.
Expression of interest form
Watch Dr Rosalind Simpson, the study Chief Investigator, speaking in this video about lichen sclerosus.