Clinical trial NCT02761122: Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen)
Official title: Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Planus
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Société de Dermatologie Française
First posted: 2016-05-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: The functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes assessed by flow cytometry.
timeFrame: 2 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service de Dermatologie du CHU de Besançon
city: Paris
country: France
facility: Service de Dermatologie de l'hôpital Saint Louis
city: Reims
country: France
facility: Service de Dermatologie du CHU de Reims
Study officials:
affiliation: Institut Pasteur
name: Marie-Lise Gougeon
role: STUDY_DIRECTOR
References: