Cellular and Molecular Biomarkers in Patients With Lichen Planus

Last updated: June 27, 2025
Sponsor: Institut Pasteur
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rash

Warts

Treatment

Skin or mucous membrane brushing

Skin or mucous membrane biopsy

Blood samples collection

Clinical Study ID

NCT06451744
2021-048
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject coming at the time of diagnosis of the disease before any systemictreatment, or at the time of a progressive episode of the disease, without systemictreatment 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

Exclusion Criteria:

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

Study Design

Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Skin or mucous membrane brushing
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • CHU de Besançon

    Besançon, 25030
    Finland

    Active - Recruiting

  • CHU de Besançon

    Besançon, 25030
    France

    Active - Recruiting

  • CHU Paris Seine-Saint-Denis- Hôpital Avicenne

    Bobigny,
    France

    Active - Recruiting

  • Centre Medical de l'Institut Pasteur

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris,
    France

    Active - Recruiting

  • Hôpital Robert Debré, CHU de Reims

    Reims, 51092
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

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