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Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus (LICHENVIR)

Primary Purpose

Lichen Planus, Oral

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

buccal cavity sample

About this trial

This is an interventional basic science trial for Lichen Planus, Oral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient ≥ 18 years
Clinical and/or histological diagnosis of erosive or atrophic OLP
No signs of severe dysplasia at the sampling

Exclusion Criteria:

o immunosuppressive or anti-inflammatory therapies at the inclusion

Sites / Locations

Hôpital saint RochRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral lichen planus disease

Arm Description

buccal cavity sample

Outcomes

Primary Outcome Measures

Measure of level of EBV nucleic acids

Secondary Outcome Measures

Full Information

NCT ID

NCT02276573

First Posted

October 24, 2014

Last Updated

October 23, 2015

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT02276573

Brief Title

Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

Acronym

LICHENVIR

Official Title

Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network. The literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of OLP remain unknown. This project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on Epstein-Barr Virus (EBV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lichen Planus, Oral

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral lichen planus disease

Arm Type

Experimental

Arm Description

buccal cavity sample

Intervention Type

Biological

Intervention Name(s)

buccal cavity sample

Primary Outcome Measure Information:

Title

Measure of level of EBV nucleic acids

Time Frame

day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient ≥ 18 years Clinical and/or histological diagnosis of erosive or atrophic OLP No signs of severe dysplasia at the sampling Exclusion Criteria: o immunosuppressive or anti-inflammatory therapies at the inclusion

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hélène RAYBAUD, MD

Phone

+(33)4 92 03 40 11

raybaud@unice.fr

Facility Information:

Facility Name

Hôpital saint Roch

City

Nice

ZIP/Postal Code

06000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène RAYBAUD, MD

Phone

+(33)4 92 03 40 11

raybaud@unice.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

30004820

Citation

Raybaud H, Olivieri CV, Lupi-Pegurier L, Pagnotta S, Marsault R, Cardot-Leccia N, Doglio A. Epstein-Barr Virus-Infected Plasma Cells Infiltrate Erosive Oral Lichen Planus. J Dent Res. 2018 Dec;97(13):1494-1500. doi: 10.1177/0022034518788282. Epub 2018 Jul 13.

Results Reference

derived

Learn more about this trial

Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

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