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

<ns3:p> Background Vulval lichen sclerosus (LS) is a chronic inflammatory condition predominantly affecting female anogenital skin. It causes distressing symptoms that impact on daily living/quality of life (QOL), as well as causing progressive anatomical changes and increased cancer risk. First-line treatment with a very strong topical corticosteroid (TCS) brings LS into remission in around 70%. It is unclear how best to treat LS long-term. The PEARLS trial (ProactivE Against Reactive treatment for Lichen Sclerosus) will answer the research question <ns3:bold>:</ns3:bold> In people ≥5 years old with vulval LS, is maintenance treatment with a TCS twice weekly (‘proactive therapy’) better than as required treatment (‘reactive therapy’) for reducing number of flares over 12-months? </ns3:p>