Health TrialsbyHealthPanel

Cellular and Molecular Biomarkers in Patients With Lichen Planus

ConditionLichen Planus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Pasteur

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood samples collection

    Other intervention

    50 mL blood sample

  • Skin or mucous membrane brushing

    Other intervention

    brushing on skin or mucous membrane lesions

  • Skin or mucous membrane biopsy

    Other intervention

    6 mm biopsy

Treatment groups

70 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Oral lichen planus erosiveExperimental treatment 3 interventions
Group B: mucosal pemphigoid with oral lesionsExperimental treatment 2 interventions
Group C: lichen planus with scalp involvementExperimental treatment 2 interventions
Group D: Pseudopelade of BrocqExperimental treatment 3 interventions
Group E: lichen planus with nail involvementExperimental treatment 2 interventions
Group F: psoriasis and specific nail involvementExperimental treatment 2 interventions
Group G: Lichenoid graft-versus-host diseaseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Identification of TCR repertoire by flow cytometry

Determination by flow cytometry and PCR testing for TCR repertoire bias

Time frame
3 years

Secondary outcomes

1

Identification of characteristic biomarkers of lichen

Identify complementary biomarkers characterising lichen by quantitative PCR

Time frame
3 years
2

Identification of T CD8 clonotypes

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Pasteur

Lead sponsor

Source ClinicalTrials.gov
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