Inflammation; SkinTRIPNCT04848194
Pleiotropic Role of TRPV1 in Psoriasis Inflammation
A study testing skin biopsy and blood sampling in people with Inflammation; Skin and Psoriasis, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation; Skin, Psoriasis
- What is being tested?
- skin biopsy and blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2021to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Inflammation; Skin, Psoriasis
- Being tested
- skin biopsy and blood sampling
- Keywords
- psoriasis, TRVP1
- Medical subject headings
- Dermatitis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsy and blood samplingProcedure or surgery
- 4 skin biopsies outside the face under local anesthesia: 2 in damaged zone, 2 in non-damage zone.
- A blood sample
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All patients with psoriasis recruted by dermatological departement. Receives: Procedure: skin biopsy and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (5)
Density changes of intra-epidermal nerve fibers expressing neuropeptides
Density of intra-epidermal nerve fibers expressing neuropeptides by immunohistochemistry
Measured: 1 day
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
Measured: 1 day
Changes in endothelial cell density between an injured and an uninjured area of the same patient
quantification of TRPV1 activity
Measured: 1 day
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Identification and quantification of the blood cytokine profile
Measured: 1 day
Changes in the density of keratinocytes and their contacts with nerve fibers
Number and distribution of contacts between keratinocytes and nerve fibers
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start22 Dec 2021
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation; SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848194
- Sponsor's protocol ID
- 29BRC21.0013
- Acronym
- TRIP
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleiotropic Role of TRPV1 in Psoriasis Inflammation
- ClinicalTrials.gov ID
- NCT04848194
- Acronym / sponsor ID
- TRIP / 29BRC21.0013
- Conditions
- Inflammation; Skin, Psoriasis
- Keywords
- psoriasis, TRVP1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Procedure: skin biopsy and blood samplingAll patients with psoriasis recruted by dermatological departement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | All patients |
Primary outcome
Role of TRPV1 receptors expressed by sensory neurons and non-neuronal cells (keratinocytes and endothelial cells) in the inflammatory process characteristic of psoriasis.
Time frame: 1 day
Density of intra-epidermal nerve fibers expressing the TRPV1 receptor
5 secondary outcomes
Density changes of intra-epidermal nerve fibers expressing neuropeptides
Time frame: 1 day
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Time frame: 1 day
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Time frame: 1 day
Changes in endothelial cell density between an injured and an uninjured area of the same patient
Time frame: 1 day
Changes in the density of keratinocytes and their contacts with nerve fibers
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy and blood sampling in people with Inflammation; Skin and Psoriasis, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of TRPV1 receptors expressed by sensory neurons and non-neuronal cells (keratinocytes and endothelial cells) in the inflammatory process characteristic of psoriasis. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.