Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
MicroPso
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedStudy Start
First participant enrolled
February 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2018
CompletedDecember 19, 2025
December 1, 2025
2.4 years
January 7, 2016
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at the latest 3 months after inclusion
Secondary Outcomes (3)
Sensory detection threshold
at the latest 3 months after inclusion
Potential discomfort sensation thresholds
at the latest 3 months after inclusion
Heat sensitivity
at the latest 3 months after inclusion
Study Arms (2)
Healthy skin
ACTIVE COMPARATORLocal 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
EXPERIMENTALLocal 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.
Interventions
Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
Eligibility Criteria
You may qualify if:
- Type I psoriasis
- Psoriasis plaques on the patient's back
You may not qualify if:
- BMI \> 25
- Diabetic patient
- Arteriovenous disease history
- Ongoing anti-inflammatory treatment
- Major cardiovascular history (\<3 months)
- Hypertension
- Topical treatment on the back skin (\<7 days)
- Systemic treatment (steroids, methotrexate, retinoids, cyclosporine) or phototherapy (\<1 month)
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie
Lyon, 69437, France
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2016
First Posted
January 11, 2016
Study Start
February 8, 2016
Primary Completion
July 16, 2018
Study Completion
July 16, 2018
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share