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

June 27, 2025 updated by: Institut Pasteur

Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25030
        • Recruiting
        • CHU de Besancon
        • Contact:
          • François Aubin, Pr
      • Bobigny, France
        • Recruiting
        • CHU Paris Seine-Saint-Denis- Hôpital Avicenne
        • Contact:
          • Frédéric Caux, Pr
      • Paris, France
        • Recruiting
        • Hopital Saint-Louis
        • Principal Investigator:
          • Jean-David Bouaziz
        • Contact:
          • Hervé Bachelez, Pr
      • Paris, France, 75015
        • Recruiting
        • Centre Médical de l'Institut Pasteur
        • Contact:
      • Reims, France, 51092
        • Recruiting
        • Hôpital Robert Debré, chu de Reims
        • Contact:
          • Manuelle Viguier, Pr
      • Rouen, France
        • Recruiting
        • CHU de ROUEN
        • Contact:
          • Pascal Joly, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
Other: Skin or mucous membrane biopsy
6 mm biopsy
Experimental: mucosal pemphigoid with oral lesions

Human biological samples :

  • blood samples collection at visit 1
  • brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
Experimental: lichen planus with scalp involvement

Human biological samples :

  • blood samples collection at visit 1
  • brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
Experimental: 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
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
Other: Skin or mucous membrane biopsy
6 mm biopsy
Experimental: lichen planus with nail involvement

Human biological samples :

  • blood samples collection at visit 1
  • brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
Experimental: psoriasis and specific nail involvement

Human biological samples :

  • blood samples collection at visit 1
  • brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions
Experimental: Lichenoid graft-versus-host disease

Human biological samples :

  • blood samples collection at visit 1
  • brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection
50 mL blood sample
Other: Skin or mucous membrane brushing
brushing on skin or mucous membrane lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of TCR repertoire by flow cytometry
Time Frame: 3 years
Determination by flow cytometry and PCR testing for TCR repertoire bias
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of characteristic biomarkers of lichen
Time Frame: 3 years
Identify complementary biomarkers characterising lichen by quantitative PCR
3 years
Identification of T CD8 clonotypes
Time Frame: 3 years
Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Investigators

  • Principal Investigator: Manuelle Vigiuer, CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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