Lichen planus (LP) is a chronic inflammatory condition that affects the skin, nails, and mucous membranes. Cutaneous LP typically presents with itchy, flat-topped, violaceous papules. LP can significantly affect quality of life due to visible disfigurement, persistent itching, or pain. Evidence on treatment efficacy is limited and difficult to compare due to heterogeneity of outcome domains and instruments. Core Outcome Sets (COS) offer a structured solution to inconsistent outcome selection. No COS currently exists for LP. Given the variability in outcomes and the emerging therapies for LP, a COS is urgently needed to improve outcomes and comparability between future studies. The Lichen planus Core Outcome Set (LiCOS) initiative is an international collaboration involving dermatologists and patient partners whose goal is to achieve consensus among expert dermatologists on a core set of outcome domains for the assessment of cutaneous LP in clinical trials.
Potentially Relevant COS:
The COS for oral lichen planus does not fully cover this domain as patients can have oral lichen planus with or without cutaneous symptoms. Furthermore, the core domains identified and survey questions do not pertain to cutaneous involvement, making the proposed LiCOS study unique.
Amit Garg (Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell)
Sanne Uitentuis (Department of Dermatology Amsterdam Public Health/Infection and Immunology, Amsterdam UMC)
Disease Category: Skin
Disease Name: Cutaneous lichen planus
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review
- Survey
An international steering group will guide the CDS development. Two stakeholder groups are involved: patients and dermatologists. The initial list of candidate items will be obtained by combining the following datasets: (1) a scoping review of the literature, (2) an online survey of patients and dermatologists to generate candidate domains of interest. To reach consensus on the COS, a minimum of 2 anonymous Delphi rounds are planned together with virtual consensus meetings to ensure global representation.