What is the study about?

Lichen Sclerosus (LS) is an itchy and distressing condition affecting vulval skin (the skin around the vagina).  It may lead to scarring if it is not treated and patients with LS are at higher risk of developing vulval cancer.
PEARLS is looking at whether using a steroid treatment regularly, even when symptoms are controlled, is better than using steroid cream only during a flare.

Who can take part in the study?

Female participants with vulval Lichen Sclerosus (LS) aged 5 years and over.

What is being tested in the study?

Potent or superpotent topical corticosteroid (TCS) to be applied on two non-consecutive days per week even in the absence of symptoms (proactive treatment).

What is this being compared to?

Potent or superpotent topical corticosteroid (TCS) to be applied as required to treat a Lichen Sclerosus (LS) flare.

What are we trying to find out?

The trial aim is to compare the clinical and cost effectiveness of a twice weekly maintenance strategy with topical corticosteroid (proactive therapy) with as required treatment (reactive therapy) in the management of vulval lichen sclerosus (LS), both shorter-term symptom control and longer-term complications, in people ≥5 years of age without signs and symptoms of active disease.

How many patients do we need?

400

Funder

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)