Cellular and Molecular Biomarkers in Patients With Lichen Planus
HELP
Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus
1 other identifier
interventional
70
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
ExpectedJuly 1, 2025
June 1, 2025
2.5 years
July 6, 2023
June 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of TCR repertoire by flow cytometry
Determination by flow cytometry and PCR testing for TCR repertoire bias
3 years
Secondary Outcomes (2)
Identification of characteristic biomarkers of lichen
3 years
Identification of T CD8 clonotypes
3 years
Study Arms (7)
Oral lichen planus erosive
EXPERIMENTALHuman 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
mucosal pemphigoid with oral lesions
EXPERIMENTALHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
lichen planus with scalp involvement
EXPERIMENTALHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Pseudopelade of Brocq
EXPERIMENTALHuman 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
lichen planus with nail involvement
EXPERIMENTALHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
psoriasis and specific nail involvement
EXPERIMENTALHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Lichenoid graft-versus-host disease
EXPERIMENTALHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Interventions
50 mL blood sample
brushing on skin or mucous membrane lesions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
Study Sites (6)
CHU de Besançon
Besançon, 25030, France
CHU Paris Seine-Saint-Denis- Hôpital Avicenne
Bobigny, France
Centre Medical de l'Institut Pasteur
Paris, 75015, France
Hôpital Saint-Louis
Paris, France
Hôpital Robert Debré, CHU de Reims
Reims, 51092, France
CHU de Rouen
Rouen, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuelle Vigiuer
CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2023
First Posted
June 11, 2024
Study Start
November 1, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share