Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis (MicroPso)

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 Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Acetylcholine iontophoresis; Other: Sodium Nitroprussiate iontophoresis; Other: ppi water iontophoresis; Other: Laser Doppler recording

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • LYON cedex 03, France, 69437
    • Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type I psoriasis
• Psoriasis plaques on the patient's back

Exclusion Criteria:

• 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
• Subject within exclusion period following a previous or ongoing biomedical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy skin; 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.	Other: Acetylcholine iontophoresis; Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Other: Sodium Nitroprussiate iontophoresis; Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Other: ppi water iontophoresis; ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Other: Laser Doppler recording; Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
Experimental: Psoriasis plaque; 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.	Other: Acetylcholine iontophoresis; Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Other: Sodium Nitroprussiate iontophoresis; Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Other: ppi water iontophoresis; ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Other: Laser Doppler recording; Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory detection threshold	Increasing size of Von Frey filaments will be placed onto patients' skin to assess sensory detection threshold.	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.	at the latest 3 months after inclusion
Heat sensitivity	Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water	at the latest 3 months after inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2016
• Primary Completion (Actual): July 16, 2018
• Study Completion (Actual): July 16, 2018

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Psoriasis; Microcirculation; TRPV1
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Cholinergic Agents; Cholinergic Agonists; Acetylcholine
• Other Study ID Numbers: 69HCL15_0425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No