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 (PEARLS)

Research summary

PEARLS is a 2-arm,parallel-group,individually randomised,open label assessor-blinded,multicentre,superiority trial with an internal pilot phase. It is a pragmatic trial and the trial participants in both intervention and comparator group will receive commonly prescribed topical corticosteroids (TCSs),which is tailored for the participant. The only difference between the treatment groups is the treatment regimen/strategy. There are number of TCS products available on the market and all available brands and forms can be prescribed to participants. Participants will be randomised to one of two treatment strategies: a. Intervention group: Potent or superpotent topical corticosteroid (TCS) to be applied on two non-consecutive days per week even in the absence of symptoms (proactive). b. Comparator group: Potent or superpotent topical corticosteroid (TCS) to be applied as required to treat a LS flare (reactive).

Principal Investigator

Dr Inge Kreuser-Genis

Contact us

Email: melanie.westmoreland@ouh.nhs.uk

IRAS number

1008267