Cellular and Molecular Biomarkers in Patients With Lichen Planus

Lichen Planus Clinical Trial

— HELP  

Official title:

Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451744
• Other study ID #: 2021-048
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Institut Pasteur
• Contact: Marie-Lise Gougeon
• Phone: 1 40 66 97 87
• Email: marie-lise.gougeon[@]pasteur.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lichen Planus

Intervention

Other:
• Blood samples collection
50 mL blood sample
• Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
• Skin or mucous membrane biopsy
6 mm biopsy

Locations

Country	Name	City	State
Finland	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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Countries where clinical trial is conducted

Finland,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of TCR repertoire by flow cytometry	Determination by flow cytometry and PCR testing for TCR repertoire bias	3 years
Secondary	Identification of characteristic biomarkers of lichen	Identify complementary biomarkers characterising lichen by quantitative PCR	3 years
Secondary	Identification of T CD8 clonotypes	Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry	3 years