Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04848194
Other study ID # 29BRC21.0013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 22, 2021
Est. completion date January 24, 2024

Study information

Verified date May 2024
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 24, 2024
Est. primary completion date January 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France TALAGAS Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 day
Secondary Density changes of intra-epidermal nerve fibers expressing neuropeptides Density of intra-epidermal nerve fibers expressing neuropeptides by immunohistochemistry 1 day
Secondary 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 1 day
Secondary Changes in endothelial cell density between an injured and an uninjured area of the same patient quantification of TRPV1 activity 1 day
Secondary Changes in endothelial cell density between an injured and an uninjured area of the same patient Identification and quantification of the blood cytokine profile 1 day
Secondary Changes in the density of keratinocytes and their contacts with nerve fibers Number and distribution of contacts between keratinocytes and nerve fibers 1 day
See also
  Status Clinical Trial Phase
Completed NCT03236870 - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed NCT00078819 - Etanercept (Enbrel®) in Psoriasis - Pediatrics Phase 3
Completed NCT04841187 - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting NCT03927352 - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis Phase 3
Completed NCT03284879 - Post-Marketing Surveillance Study of OTEZLA
Recruiting NCT06027034 - Effectiveness of a Digital Health Application for Psoriasis N/A
Not yet recruiting NCT06050330 - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study N/A
Recruiting NCT05744466 - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed NCT04149587 - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed NCT01384630 - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis Phase 2
Completed NCT03998683 - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis Phase 3
Terminated NCT03556202 - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) Phase 3
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06077331 - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT04316585 - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants Phase 1
Completed NCT04894890 - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed NCT00358384 - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034 Phase 1
Completed NCT03757013 - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Completed NCT05003531 - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Phase 2