Cellular and Molecular Biomarkers in Patients With Lichen Planus

Not Applicable

Recruiting

• Conditions: Lichen Planus

• Registration Number: NCT06451744
• Lead Sponsor: Institut Pasteur

Brief Summary

Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. In previous work, T cell antigen receptor (TCR) repertoire studies were performed. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.

Detailed Description

Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. Several triggers have been proposed for LP, including viral antigens. In previous work, T cell antigen receptor (TCR) repertoire studies were performed, i.e. investigating the diversity of TCRs expressed on the surface of an individual's lymphocyte population. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.

Study Timeline

• Study First Submitted: 2023-07-06
• Study Start: 2023-11-01
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Subject coming at the time of diagnosis of the disease before any systemic treatment, or at the time of a progressive episode of the disease, without systemic treatment or after cessation of immunomodulatory or immunosuppressive treatment
• Ability to give their consent in writing
• Must understand spoken and written French
• Affiliated to the French social security or assimilated regimes

Exclusion Criteria

• Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Identification of TCR repertoire by flow cytometry	3 years	Determination by flow cytometry and PCR testing for TCR repertoire bias

Secondary Outcome Measures

Name	Time	Method
Identification of characteristic biomarkers of lichen	3 years	Identify complementary biomarkers characterising lichen by quantitative PCR
Identification of T CD8 clonotypes	3 years	Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry

Trial Locations

Locations (6)

Centre Medical de l'Institut Pasteur; 🇫🇷 Paris, France

CHU de Besançon; 🇫🇷 Besançon, France

CHU Paris Seine-Saint-Denis- Hôpital Avicenne; 🇫🇷 Bobigny, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Hôpital Robert Debré, CHU de Reims; 🇫🇷 Reims, France

CHU de Rouen; 🇫🇷 Rouen, France