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

November 15, 2023 updated by: Centre Hospitalier Universitaire de Nice

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

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

  • Name: Hélène RAYBAUD, MD
  • Phone Number: +(33)4 92 03 40 11
  • Email: raybaud@unice.fr

Study Locations

  • France
      • Nice, France, 06000
        • Hôpital Saint Roch

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral lichen planus disease
buccal cavity sample
Biological: buccal cavity sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of level of EBV nucleic acids
Time Frame: day 1
day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 30, 2015

Primary Completion (Actual)

March 10, 2016

Study Completion (Actual)

March 10, 2016

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimated)

October 28, 2014

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-AOI-02

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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