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Cellular and Molecular Biomarkers in Patients With Lichen Planus (HELP)

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Pasteur Institute

Status

Enrolling

Conditions

Lichen Planus

Treatments

Other: Blood samples collection
Other: Skin or mucous membrane biopsy
Other: Skin or mucous membrane brushing

Study type

Interventional

Funder types

Industry

Identifiers

NCT06451744
2021-048

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 7 patient groups

Oral lichen planus erosive
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 and 2 (6 month after first visit) * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 and 2
Treatment:
Other: Skin or mucous membrane brushing
Other: Skin or mucous membrane biopsy
Other: Blood samples collection
mucosal pemphigoid with oral lesions
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Treatment:
Other: Skin or mucous membrane brushing
Other: Blood samples collection
lichen planus with scalp involvement
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Treatment:
Other: Skin or mucous membrane brushing
Other: Blood samples collection
Pseudopelade of Brocq
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1
Treatment:
Other: Skin or mucous membrane brushing
Other: Skin or mucous membrane biopsy
Other: Blood samples collection
lichen planus with nail involvement
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Treatment:
Other: Skin or mucous membrane brushing
Other: Blood samples collection
psoriasis and specific nail involvement
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Treatment:
Other: Skin or mucous membrane brushing
Other: Blood samples collection
Lichenoid graft-versus-host disease
Experimental group
Description:
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Treatment:
Other: Skin or mucous membrane brushing
Other: Blood samples collection

Trial contacts and locations

6

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Central trial contact

Sandrine Fernandes Pellerin; Marie-Lise Gougeon

Data sourced from clinicaltrials.gov

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