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NCT Number: NCT06451744

Cellular and Molecular Biomarkers in Patients With Lichen Planus

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood samples collection

Other

50 mL blood sample

Skin or mucous membrane brushing

Other

brushing on skin or mucous membrane lesions

Skin or mucous membrane biopsy

Other

6 mm biopsy

Primary outcomes

  1. Identification of TCR repertoire by flow cytometry

    Time frame: 3 years

    Determination by flow cytometry and PCR testing for TCR repertoire bias

Secondary outcomes

  1. Identification of characteristic biomarkers of lichen

    Time frame: 3 years

    Identify complementary biomarkers characterising lichen by quantitative PCR

  2. Identification of T CD8 clonotypes

    Time frame: 3 years

    Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Lise Gougeon

CONTACT

[email protected]

1 40 66 97 87

Sandrine Fernandes Pellerin

CONTACT

[email protected]

1 45 68 81 79

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Official study title

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

Acronym: HELP

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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