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Trial record 18 of 25 for:    "Lichen Sclerosus"

Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen) (HPVLichen)

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ClinicalTrials.gov Identifier: NCT02761122
Recruitment Status : Active, not recruiting
First Posted : May 4, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
Institut Pasteur

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.


Condition or disease Intervention/treatment Phase
Lichen Planus Procedure: Human biological samples Not Applicable

Detailed Description:

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 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.

Regarding erosive lichen planus, the aim is to test the cytotoxic function of the previously identified CD8 T lymphocytes specific for HPV16 E711-20.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human
Actual Study Start Date : May 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with lichen

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
  • Blood sample
  • Skin or mucosal brushing
  • Skin or mucosal biopsy




Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

    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.



Secondary Outcome Measures :
  1. The functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes assessed by flow cytometry. [ Time Frame: 2 years ]
    In patients with erosive lichen planus, the functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes will be assessed showing their ability to recognize and destroy a target carrier of HPV16 E711-20 peptide by flow cytometry.



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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:

  • 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

Exclusion Criteria:

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

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): NCT02761122


Locations
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France
Service de Dermatologie du CHU de Besançon
Besançon, France
Service de Dermatologie de l'hôpital Saint Louis
Paris, France
Service de Dermatologie du CHU de Reims
Reims, France
Sponsors and Collaborators
Institut Pasteur
Société de Dermatologie Française
Investigators
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Study Director: Marie-Lise Gougeon Institut Pasteur

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT02761122     History of Changes
Other Study ID Numbers: 2015-058
ID-RCB number : 2015-A01697-42 ( Other Identifier: French national registration number of the study )
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases