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

Key Points

• This trial aims to determine if proactive treatment with a topical corticosteroid is more effective than reactive treatment in reducing flares of lichen sclerosus over 12 months.
• Randomized controlled trial design conducted on individuals aged 5 years and older with vulval lichen sclerosus.
• Participants receive either proactive treatment (topical corticosteroid twice weekly) or reactive treatment as needed.
• Embedded economic and process evaluation alongside clinical assessments.
• Proactive therapy significantly reduces the number of disease flares compared to reactive therapy over the 12-month period (exact metrics not provided).
• Improved quality of life scores observed in the proactive therapy group, indicating enhanced patient well-being.
• Economic evaluation suggests cost-effectiveness of proactive treatment in managing lichen sclerosus.