Clinical trial NCT06451744: Cellular and Molecular Biomarkers in Patients With Lichen Planus
Official title: Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lichen Planus
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Identification of TCR repertoire by flow cytometry
timeFrame: 3 years
Secondary outcomes:
measure: Identification of characteristic biomarkers of lichen
timeFrame: 3 years
measure: Identification of T CD8 clonotypes
timeFrame: 3 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Bobigny
country: France
facility: CHU Paris Seine-Saint-Denis- Hôpital Avicenne
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Reims
country: France
facility: Hôpital Robert Debré, CHU de Reims
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims
name: Manuelle Vigiuer
role: PRINCIPAL_INVESTIGATOR
References: