Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Other: Acetylcholine iontophoresis; Other: Sodium Nitroprussiate iontophoresis; Other: ppi water iontophoresis; Other: Laser Doppler recording

• Registration Number: NCT02652065
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Study Start: 2016-02-08
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy skin	Acetylcholine iontophoresis	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.
Healthy skin	ppi water iontophoresis	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.
Psoriasis plaque	ppi water iontophoresis	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.
Psoriasis plaque	Sodium Nitroprussiate iontophoresis	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.
Healthy skin	Sodium Nitroprussiate iontophoresis	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.
Healthy skin	Laser Doppler recording	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.
Psoriasis plaque	Acetylcholine iontophoresis	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.
Psoriasis plaque	Laser Doppler recording	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.

Primary Outcome Measures

Name	Time	Method
skin blood flow variation	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.

Secondary Outcome Measures

Name	Time	Method
Sensory detection threshold	at the latest 3 months after inclusion	Increasing size of Von Frey filaments will be placed onto patients' skin to assess sensory detection threshold.
Potential discomfort sensation thresholds	at the latest 3 months after inclusion	Increasing size of Von Frey filaments will be placed onto patients' skin to assess potential discomfort sensation threshold.
Heat sensitivity	at the latest 3 months after inclusion	Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water

Trial Locations

Locations (1)

Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie; 🇫🇷 LYON cedex 03, France