PEARLS - ProactivE Against Reactive treatment for Lichen Sclerosus
Research type
Research Study
Full title
Proactive against reactive therapy for the prevention of lichen sclerosus exacerbation and progression of disease – a pragmatic, parallel group randomised controlled trial with embedded economic evaluation and process evaluation
IRAS ID
1008267
Contact name
Roaslind Simpson
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN72275160
Clinicaltrials.gov Identifier
Research summary
Lichen sclerosus (LS) is a long term, itchy and distressing condition affecting vulval skin (the skin around the outside of the vagina). It needs ongoing treatment with steroid creams to manage flares of symptoms. If untreated, it may lead to scarring causing the labia minora (inner lips) to fuse together or the entrance to the vagina to narrow. People with LS are at higher risk of developing vulval cancer.
Vulval LS can affect everyone, but most commonly children and women of any age, particularly women who have gone through the menopause and children before puberty.
This trial will try to find out what the is the best way to manage future flares of LS: using a steroid treatment regularly (e.g. twice a week), even when symptoms are controlled OR using a steroid cream only during a flare.
We will enrol 400 females (aged 5 years and over) and randomly allocate half to use their steroid cream twice a week,
and half to only use it if they experience symptoms. We will compare how many people in each group develop LS flares. With the optional consent of the participant/parent/guardian, photographs will be taken at baseline to check if scarring worsens during the trial. We will follow patients for two years to gather data to answer our questions. With participants’ consent (optional), we will check their medical records at a later stage (after the trial ends) to see how many patients in each treatment group develop cancer. We will conduct an optional qualitative study and interview patients (those who consented to participate in qualitative sub-study) to explore how they feel about the trial 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 trial to see if one is better value for money for the NHS. If successful, the trial results will be used to change clinical practice for treatment of patients with LS.REC name
South West - Central Bristol Research Ethics Committee
REC reference
24/SW/0016
Date of REC Opinion
7 Mar 2024
REC opinion
Further Information Favourable Opinion