Pleiotropic Role of TRPV1 in Psoriasis Inflammation (TRIP)
Primary Purpose
Inflammation; Skin, Psoriasis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
skin biopsy and blood sampling
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation; Skin focused on measuring psoriasis, TRVP1
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years old with psoriasis, with or without itching (pruritus).
- Presence of lesional and non lesional zones, in unexposed areas and surface area (outside the face and folds) large enough to allow the biopsies to be performed
- Patients who have given written consent
Exclusion Criteria:
- Patients with physical or psychological incapacity to sign consent
- Patients not covered by the Social Security system
- Patients with topical treatments for psoriasis,
- Patients with systemic treatments for psoriasis,
- Patients allergic to lidocaine
- Patients over the age of majority who are subject to legal protection or who are unable to give consent
- Patients deprived of liberty by a judicial or administrative decision
- Pregnant women, parturients and breastfeeding mothers
Sites / Locations
- TALAGASRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
All patients with psoriasis recruted by dermatological departement.
Outcomes
Primary Outcome Measures
Role of TRPV1 receptors expressed by sensory neurons and non-neuronal cells (keratinocytes and endothelial cells) in the inflammatory process characteristic of psoriasis.
Density of intra-epidermal nerve fibers expressing the TRPV1 receptor
Secondary Outcome Measures
Density changes of intra-epidermal nerve fibers expressing neuropeptides
Density of intra-epidermal nerve fibers expressing neuropeptides by immunohistochemistry
Changes in endothelial cell density between an injured and an uninjured area of the same patient
quantification of the transcriptional and protein expression of TRPV1
Changes in endothelial cell density between an injured and an uninjured area of the same patient
quantification of TRPV1 activity
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Identification and quantification of the blood cytokine profile
Changes in the density of keratinocytes and their contacts with nerve fibers
Number and distribution of contacts between keratinocytes and nerve fibers
Full Information
NCT ID
NCT04848194
First Posted
April 7, 2021
Last Updated
February 8, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04848194
Brief Title
Pleiotropic Role of TRPV1 in Psoriasis Inflammation
Acronym
TRIP
Official Title
Pleiotropic Role of TRPV1 in Psoriasis Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Widely expressed in the sensory nerve endings of the skin, Transient Receptor Potential Vanilloid 1 (TRPV1) is a receptor that plays an important role in the perception of pain and pruritus but also in skin inflammation, primarily by inducing the local release of several neuropeptides.
Although the mechanisms by which TRPV1-sensitizing inflammatory mediators in damaged skin have received considerable attention, the role of TRPV1 in psoriasis has so far been little explored.
However, two studies have reported that ablation of sensory nerves expressing TRPV1 reduced psoriasiform skin inflammation, demonstrating the neuronal contribution to inflammation in psoriasis.
However, the expression of TRPV1 is not limited to neurons alone. TRPV1 is also expressed by epidermal keratinocytes and skin microvessels.
For example, in 2018, transcriptomic analysis of psoriatic patient skins (by definition devoid of neuron nuclei) revealed that TRPV1 expression was increased in the skin of psoriatic patients suffering from itching (pruritus).
Regarding human keratinocytes, it is recognized that the activation of TRPV1 present on their surface induces the release of pro-inflammatory factors such as cyclooxygenase-2. In addition, the investigators have demonstrated that TRPV1 has a pivotal role in the keratinocyte production of inflammatory mediators, which is mediated by the protease-activated receptor-2 (PAR-2). However, the role of vascular TRPV1 in inflammation is not described.
The investigators hypothesize that in addition to neuronal TRPV1, non-neuronal TRPV1 receptors of non-neuronal cells (keratinocytes and endothelial cells) may be involved in the vicious circle of the inflammatory process characteristic of psoriasis. Putting TRPV1 at the center of the deregulation of the homeostatic balance including epithelial, neuronal and vascular inflammation in psoriasis is totally innovative.
Detailed Description
Each patient will have a sample taken in the dermatology department:
4 skin biopsies
A blood sample.
Patients with psoriasis will be recruited from the dermatology department. There will be no further visits, so the duration of the study is 1 day.
The samples taken will be used to determine the pleiotropic role of TRPV1 in Psoriasis Inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation; Skin, Psoriasis
Keywords
psoriasis, TRVP1
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
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Arm Description
All patients with psoriasis recruted by dermatological departement.
Intervention Type
Procedure
Intervention Name(s)
skin biopsy and blood sampling
Intervention Description
4 skin biopsies outside the face under local anesthesia: 2 in damaged zone, 2 in non-damage zone.
A blood sample
Primary Outcome Measure Information:
Title
Role of TRPV1 receptors expressed by sensory neurons and non-neuronal cells (keratinocytes and endothelial cells) in the inflammatory process characteristic of psoriasis.
Description
Density of intra-epidermal nerve fibers expressing the TRPV1 receptor
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Density changes of intra-epidermal nerve fibers expressing neuropeptides
Description
Density of intra-epidermal nerve fibers expressing neuropeptides by immunohistochemistry
Time Frame
1 day
Title
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Description
quantification of the transcriptional and protein expression of TRPV1
Time Frame
1 day
Title
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Description
quantification of TRPV1 activity
Time Frame
1 day
Title
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Description
Identification and quantification of the blood cytokine profile
Time Frame
1 day
Title
Changes in the density of keratinocytes and their contacts with nerve fibers
Description
Number and distribution of contacts between keratinocytes and nerve fibers
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years old with psoriasis, with or without itching (pruritus).
Presence of lesional and non lesional zones, in unexposed areas and surface area (outside the face and folds) large enough to allow the biopsies to be performed
Patients who have given written consent
Exclusion Criteria:
Patients with physical or psychological incapacity to sign consent
Patients not covered by the Social Security system
Patients with topical treatments for psoriasis,
Patients with systemic treatments for psoriasis,
Patients allergic to lidocaine
Patients over the age of majority who are subject to legal protection or who are unable to give consent
Patients deprived of liberty by a judicial or administrative decision
Pregnant women, parturients and breastfeeding mothers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu TALAGAS, PhD
Phone
2 98 01 64 38
Ext
+33
Email
matthieu.talagas@chu-brest.fr
Facility Information:
Facility Name
TALAGAS
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu TALAGAS
Email
matthieu.talagas@chu-brest.fr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Learn more about this trial
Pleiotropic Role of TRPV1 in Psoriasis Inflammation
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