NCT02761122

Brief Summary

Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant peptide of Human Papilloma Virus (HPV) 16. In line with this recent work which shows for the first time a link between HPV-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 17, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2018

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

April 22, 2016

Last Update Submit

July 10, 2025

Conditions

Lichen Planus

Outcome Measures

Primary Outcomes (1)

  • The use of the different segments of the Vbeta gene assessed by quantitative PCR, and the distribution of the different sizes of the complementarity determining regions (CDR) CDR3 by immunoscope.

    In patients with a non-erosive type of lichen and with a lichen sclerosus et atrophicus, the hypothesis for oligoclonal bias in the T-cell receptor repertoire on peripheral and in situ CD4 and CD8 T lymphocytes will be tested realizing, on the 2 sorted subpopulations, a study of the use of the different segments of the Vbeta gene using quantitative Polymerase Chain Reaction (PCR) and a study of the distribution study of the different sizes of the CDR3 using immunoscope method. Depending on whether or not bias in the T-cell receptor repertoire exists, the study will be continued by looking for the same repertoire bias in situ, on injury site (skin or mucous, depending on the clinical type of lichen), and the research of clonal sequences (or clonotypes) from RNA of patients after cloning and complete sequencing. If clonotype T CD8 Vbeta3 are identified in these types of lichen, their specificity to HPV16 E711-20 wil be assessed by flow cytometry.

    2 years

Secondary Outcomes (1)

  • The functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes assessed by flow cytometry.

    2 years

Study Arms (1)

Patients with lichen

EXPERIMENTAL

Patients with non-erosive lichen planus, erosive lichen planus or lichen sclerosus. Human biological samples : * Blood sample * Skin or mucosal brushing * Skin or mucosal biopsy

Procedure: Human biological samples

Interventions

Human biological samplesPROCEDURE

* Blood sample * Skin or mucosal brushing * Skin or mucosal biopsy

Patients with lichen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 year-old
  • Clinically or histologically confirmed lichen : Non-erosive lichen planus, Erosive lichen planus, or Sclerosus lichen
  • At diagnosis of desease before treatment, or during flares of the disease, with or without intake or topical application of immunosuppressants
  • Affiliated or beneficiary of a social security system
  • Informed and written consent

You may not qualify if:

  • Under 18 year-old,
  • Legal protection measures,
  • Inability to consent
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Dermatologie du CHU de Besançon

Besançon, France

Location

Service de Dermatologie de l'hôpital Saint Louis

Paris, France

Location

Service de Dermatologie du CHU de Reims

Reims, France

Location

Related Publications (1)

  • Viguier M, Perals C, Poirier B, Battistella M, Aubin F, Bachelez H, Pretet JL, Gheit T, Tommasino M, Touze A, Gougeon ML, Fazilleau N. Human papilloma virus-16-specific CD8+ T-cell expansions characterize different clinical forms of lichen planus and not lichen sclerosus et atrophicus. Exp Dermatol. 2023 Jun;32(6):859-868. doi: 10.1111/exd.14788. Epub 2023 Mar 15.

    PMID: 36922453BACKGROUND

MeSH Terms

Conditions

Lichen Planus

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Marie-Lise Gougeon

    Institut Pasteur

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 4, 2016

Study Start

May 17, 2016

Primary Completion

April 16, 2018

Study Completion

April 16, 2018

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)