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Cellular and Molecular Biomarkers in Patients With Lichen Planus

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06451744
Acronym
HELP
Enrollment
70
Registered
2024-06-11
Start date
2023-11-01
Completion date
2027-04-30
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lichen Planus

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.

Interventions

50 mL blood sample

OTHERSkin or mucous membrane brushing

brushing on skin or mucous membrane lesions

OTHERSkin or mucous membrane biopsy

6 mm biopsy

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Identification of TCR repertoire by flow cytometry3 yearsDetermination by flow cytometry and PCR testing for TCR repertoire bias

Secondary

MeasureTime frameDescription
Identification of characteristic biomarkers of lichen3 yearsIdentify complementary biomarkers characterising lichen by quantitative PCR
Identification of T CD8 clonotypes3 yearsMeasurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry

Countries

France

Contacts

Primary ContactMarie-Lise Gougeon
marie-lise.gougeon@pasteur.fr1 40 66 97 87
Backup ContactSandrine Fernandes Pellerin
sandrine.fernandes-pellerin@pasteur.fr1 45 68 81 79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026