PEARLS Trial: Help us to find the best management for Lichen Sclerosus
Trial ends: 1 June 2025
The University of Nottingham is running a trial to find out the most effective topical corticosteroid applicaition for the management of Lichen Sclerosus, here's how you can take part.
What is lichen sclerosus?
Vulval Lichen Sclerosus (LS) is a chronic inflammatory condition, with incidence peaking in childhood and post-menopause. Reported prevalence is up to 3%, affecting around 1 million women in the UK. Inflammation causes whitening of vulval tissue, bleeding under the skin, texture change and cuts.
Patients report itching, pain (particularly during sex) and discomfort in daily activities. Untreated LS can cause progressive loss of vulval architecture. Scarring may occur early in the disease and is irreversible without surgery. LS persisting beyond puberty may prevent normal vulval anatomical development.
What is the trial?
In order to find out the best treatment for the condition, the University of Nottingham is hoping to recruit 400 women diagnosed with the condition, over the age of five.
The 12 month trial will compare a topical corticosteroid (TCS) applied on two non-consecutive days per week, even in absence of symptoms, (‘proactive treatment’) versus TCS as required to use only to treat a flare until symptoms resolve (‘reactive treatment’), for 12 months. The treatments will not be blinded. Choice of potent/superpotent TCS preparation is tailored to the patient as not all patients can tolerate a specific formulation.
How can I take part?
Trial participants will be recruited from across the UK. There are 15 recruiting centres across the UK which you will be reffered to after being identified as a participant against identified with pre-defined eligibility criteria.
What is the time commitment?
Researchers will follow participants for two years to gather data to answer our questions. They will also ask for permission from patients to check their medical records for a number of years after the study. This will help them to see how many patients in each treatment group get cancer.
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