Pleiotropic Role of TRPV1 in Psoriasis Inflammation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04848194
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Brest
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammation; Skin, Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Other: All patients

All patients with psoriasis recruted by dermatological departement.

Interventions

Procedure: - skin biopsy and blood sampling

4 skin biopsies outside the face under local anesthesia: 2 in damaged zone, 2 in non-damage zone. A blood sample

Contact a Trial Team

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International Sites

TALAGAS, Brest, France

Status

Recruiting

Address

TALAGAS

Brest, , 29200

Site Contact

Matthieu TALAGAS

matthieu.talagas@chu-brest.fr

2 98 01 64 38

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