Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement

Area of Science:

• Dermatology
• Clinical Trials Methodology
• Patient-Reported Outcomes

Background:

• Lichen sclerosus (LS) is a chronic inflammatory genital skin condition with significant impact on quality of life (QoL).
• LS can cause progressive anatomical changes and carries a risk of cancer.
• Current LS clinical trials vary in quality and lack standardized outcome measures, hindering meta-analysis.

Purpose of the Study:

• To achieve international consensus on essential outcome domains for interventional trials in genital LS.
• To establish a Core Outcome Set (COS) for consistent measurement of treatment response in LS.

Main Methods:

• A multi-stakeholder international electronic-Delphi (e-Delphi) consensus study was conducted.
• Potential outcome domains were identified through literature review and a priority-setting partnership.
• Final agreement on domains was reached through online consensus meetings with international stakeholders.

Main Results:

• 123 participants from 20 countries completed the e-Delphi study.
• Three outcome domains were identified as 'critical': symptoms, LS-specific quality of life (QoL), and clinical (visible) signs.
• Consensus was achieved for symptoms (100%), QoL (92%), and clinical signs (97%).

Conclusions:

• International agreement has been reached on three core outcome domains for genital LS clinical trials.
• These domains (symptoms, QoL, clinical signs) should be incorporated into future LS trial protocols.
• The CORALS initiative will proceed to select outcome measurement instruments for these prioritized domains.