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Cellular and Molecular Biomarkers in Patients With Lichen Planus

NCT ID: NCT06451744

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lichen Planus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Oral lichen planus erosive

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

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

Skin or mucous membrane biopsy

Intervention Type OTHER

6 mm biopsy

mucosal pemphigoid with oral lesions

Human biological samples :

* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

lichen planus with scalp involvement

Human biological samples :

* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

Pseudopelade of Brocq

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

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

Skin or mucous membrane biopsy

Intervention Type OTHER

6 mm biopsy

lichen planus with nail involvement

Human biological samples :

* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

psoriasis and specific nail involvement

Human biological samples :

* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

Lichenoid graft-versus-host disease

Human biological samples :

* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1

Group Type EXPERIMENTAL

Blood samples collection

Intervention Type OTHER

50 mL blood sample

Skin or mucous membrane brushing

Intervention Type OTHER

brushing on skin or mucous membrane lesions

Interventions

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Blood samples collection

50 mL blood sample

Intervention Type OTHER

Skin or mucous membrane brushing

brushing on skin or mucous membrane lesions

Intervention Type OTHER

Skin or mucous membrane biopsy

6 mm biopsy

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuelle Vigiuer

Role: PRINCIPAL_INVESTIGATOR

CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims

Locations

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CHU de Besançon

Besançon, , France

Site Status RECRUITING

CHU Paris Seine-Saint-Denis- Hôpital Avicenne

Bobigny, , France

Site Status RECRUITING

Centre Medical de l'Institut Pasteur

Paris, , France

Site Status RECRUITING

Hôpital Saint-Louis

Paris, , France

Site Status RECRUITING

Hôpital Robert Debré, CHU de Reims

Reims, , France

Site Status RECRUITING

CHU de Rouen

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie-Lise Gougeon

Role: CONTACT

[email protected]
1 40 66 97 87

Sandrine Fernandes Pellerin

Role: CONTACT

[email protected]
1 45 68 81 79

Facility Contacts

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François Aubin, Pr

Role: primary

Frédéric Caux, Pr

Role: primary

Fabien Taieb, Dr

Role: primary

[email protected]
+33145688088

Hervé Bachelez, Pr

Role: primary

Manuelle Viguier, Pr

Role: primary

Pascal Joly, Pr

Role: primary

Other Identifiers

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2021-048

Identifier Type: -

Identifier Source: org_study_id

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