PsoriasisMicroPsoNCT02652065
Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
A study testing Acetylcholine iontophoresis, Sodium Nitroprussiate iontophoresis and ppi water iontophoresis in people with Psoriasis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Acetylcholine iontophoresis, Sodium Nitroprussiate iontophoresis and ppi water iontophoresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2016to 16 Jul 2018
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type I psoriasis
- Psoriasis plaques on the patient's back
Who cannot join
- BMI > 25
- Diabetic patient
- Arteriovenous disease history
- Ongoing anti-inflammatory treatment
- Major cardiovascular history (<3 months)
- Hypertension
Show all 10Show fewer
- Topical treatment on the back skin (<7 days)
- Systemic treatment (steroids, methotrexate, retinoids, cyclosporine) or phototherapy (<1 month)
- Pregnant women
- Subject within exclusion period following a previous or ongoing biomedical study
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie
Lyon, 69437
About this study
Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.
Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.
Read more
The investigators hypothesize that there is a link between cutaneous sensory neuropathies and altered cutaneous microcirculation during psoriasis.
In order to test this hypothesis, local vasodilators will be delivered to patients by iontophoresis and their skin blood flow in response to these molecules will be followed by laser Doppler recordings. Two recordings will be performed for each patient, both on a psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal control.
- Conditions
- Psoriasis
- Being tested
- Acetylcholine iontophoresis, Sodium Nitroprussiate iontophoresis, ppi water iontophoresis, Laser Doppler recording
- Keywords
- Psoriasis, Microcirculation, TRPV1
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylcholine iontophoresisOther
Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
Sodium Nitroprussiate iontophoresisOther
Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
ppi water iontophoresisOther
ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
Laser Doppler recordingOther
Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
| Study group | Role | What they receive |
|---|---|---|
| Healthy skin | Active comparator | Local vasodilators (acetylcholine, sodium nitroprussiate and ppi water as control) will be delivered to patients by iontophoresis on healthy skin.
The skin blood flow in response to these molecules will be followed by laser Doppler recordings. Receives: Other: Acetylcholine iontophoresis; Other: Sodium Nitroprussiate iontophoresis; Other: ppi water iontophoresis; Other: Laser Doppler recording |
| Psoriasis plaque | Experimental | Local vasodilators (acetylcholine, sodium nitroprussiate and ppi water as control) will be delivered to patients by iontophoresis on a psoriasis plaque (on the patient's back).
The skin blood flow in response to these molecules will be followed by laser Doppler recordings. Receives: Other: Acetylcholine iontophoresis; Other: Sodium Nitroprussiate iontophoresis; Other: ppi water iontophoresis; Other: Laser Doppler recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin blood flow variation
Skin blood flow variation on healthy skin and on psoriasis plaque will be measured by Laser Doppler in response to iontophoretic delivery of vasodilator substances (sodium nitroprussiate and acetylcholine) and ppi water. Skin blood flow will be recorded during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
Measured: at the latest 3 months after inclusion
Secondary outcomes (3)
Sensory detection threshold
Increasing size of Von Frey filaments will be placed onto patients' skin to assess sensory detection threshold.
Measured: at the latest 3 months after inclusion
Potential discomfort sensation thresholds
Increasing size of Von Frey filaments will be placed onto patients' skin to assess potential discomfort sensation threshold.
Measured: at the latest 3 months after inclusion
Heat sensitivity
Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water
Measured: at the latest 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start8 Feb 2016
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652065
- Sponsor's protocol ID
- 69HCL15_0425
- Acronym
- MicroPso
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Le seuil de sensibilité tactile est augmenté sur les plaques de psoriasis comparée à celui des zones saines. Cette diminution de sensibilité tactile apparaît en absence de défaut de sensibilité sensorielle thermique ou vibratoire ou de discrimination tactile (test PIC/TOUCHE). L'exploration fonctionnelle de la microcirculation cutanée montre une perfusion fortement augmentée sur les plaques de psoriasis comparée à celle des zones saines. La microcirculation cutanée augmente en réponse à un chauffage local sur les 2 zones étudiées avec une amplitude plus marquée sur les plaques de psoriasis. La vasodilatation en réponse à l'application iontophorétique d'acétylcholine montre des résultats similaires. Ces réponses exacerbées pourraient être liées aux facteurs inflammatoires locaux, ce qui reste à démontrer dans le futur. - Conclusion : cette étude a permis de montrer des défauts de microcirculation cutanée sur les plaques de psoriasis, en l'absence de neuropathie sensorielle.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
- ClinicalTrials.gov ID
- NCT02652065
- Acronym / sponsor ID
- MicroPso / 69HCL15_0425
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Microcirculation, TRPV1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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.
Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.
Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.
The investigators hypothesize that there is a link between cutaneous sensory neuropathies and altered cutaneous microcirculation during psoriasis.
In order to test this hypothesis, local vasodilators will be delivered to patients by iontophoresis and their skin blood flow in response to these molecules will be followed by laser Doppler recordings. Two recordings will be performed for each patient, both on a psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy skin | Active comparator | Other: Acetylcholine iontophoresis, Other: Sodium Nitroprussiate iontophoresis, Other: ppi water iontophoresis, Other: Laser Doppler recordingLocal vasodilators (acetylcholine, sodium nitroprussiate and ppi water as control) will be delivered to patients by iontophoresis on healthy skin. The skin blood flow in response to these molecules will be followed by laser Doppler recordings. |
| Psoriasis plaque | Experimental | Other: Acetylcholine iontophoresis, Other: Sodium Nitroprussiate iontophoresis, Other: ppi water iontophoresis, Other: Laser Doppler recordingLocal vasodilators (acetylcholine, sodium nitroprussiate and ppi water as control) will be delivered to patients by iontophoresis on a psoriasis plaque (on the patient's back). The skin blood flow in response to these molecules will be followed by laser Doppler recordings. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Type I psoriasis
- Psoriasis plaques on the patient's back
Key exclusion criteria (10 listed)
- BMI > 25
- Diabetic patient
- Arteriovenous disease history
- Ongoing anti-inflammatory treatment
- Major cardiovascular history (<3 months)
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 |
|---|---|---|
| Acetylcholine iontophoresisAcetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization). | Other | Healthy skin, Psoriasis plaque |
| Sodium Nitroprussiate iontophoresisSodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization). | Other | Healthy skin, Psoriasis plaque |
| ppi water iontophoresisppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization). | Other | Healthy skin, Psoriasis plaque |
| Laser Doppler recordingSkin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators. | Other | Healthy skin, Psoriasis plaque |
Primary outcome
skin blood flow variation
Time frame: at the latest 3 months after inclusion
Skin blood flow variation on healthy skin and on psoriasis plaque will be measured by Laser Doppler in response to iontophoretic delivery of vasodilator substances (sodium nitroprussiate and acetylcholine) and ppi water. Skin blood flow will be recorded during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
3 secondary outcomes
Sensory detection threshold
Time frame: at the latest 3 months after inclusion
Potential discomfort sensation thresholds
Time frame: at the latest 3 months after inclusion
Heat sensitivity
Time frame: at the latest 3 months after inclusion
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 19 Dec 2025.
- Results publicationLe seuil de sensibilité tactile est augmenté sur les plaques de psoriasis comparée à celui des zones saines. Cette diminution de sensibilité tactile apparaît en absence de défaut de sensibilité sensorielle thermique ou vibratoire ou de discrimination tactile (test PIC/TOUCHE). L'exploration fonctionnelle de la microcirculation cutanée montre une perfusion fortement augmentée sur les plaques de psoriasis comparée à celle des zones saines. La microcirculation cutanée augmente en réponse à un chauffage local sur les 2 zones étudiées avec une amplitude plus marquée sur les plaques de psoriasis. La vasodilatation en réponse à l'application iontophorétique d'acétylcholine montre des résultats similaires. Ces réponses exacerbées pourraient être liées aux facteurs inflammatoires locaux, ce qui reste à démontrer dans le futur. - Conclusion : cette étude a permis de montrer des défauts de microcirculation cutanée sur les plaques de psoriasis, en l'absence de neuropathie sensorielle.
- Individual participant dataSharing planned: No
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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 Acetylcholine iontophoresis, Sodium Nitroprussiate iontophoresis and ppi water iontophoresis in people with Psoriasis, run by Hospices Civils de Lyon 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 2 inclusion and 10 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 19 Dec 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?
skin blood flow variation (time frame: at the latest 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652065, which also lists 1 linked publication.
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 19 Dec 2025.