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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276573
Recruitment Status : Unknown
Verified July 2015 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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).


Condition or disease Intervention/treatment Phase
Lichen Planus, Oral Biological: buccal cavity sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016

Arm Intervention/treatment
Experimental: Oral lichen planus disease
buccal cavity sample
Biological: buccal cavity sample



Primary Outcome Measures :
  1. Measure of level of EBV nucleic acids [ Time Frame: day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276573


Contacts
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Contact: Hélène RAYBAUD, MD +(33)4 92 03 40 11 raybaud@unice.fr

Locations
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France
Hôpital saint Roch Recruiting
Nice, France, 06000
Contact: Hélène RAYBAUD, MD    +(33)4 92 03 40 11    raybaud@unice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02276573    
Other Study ID Numbers: 14-AOI-02
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases