Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

NCT ID: NCT02652065

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-08

Study Completion Date

2018-07-16

Brief Summary

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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

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Conditions

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Psoriasis

Keywords

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Psoriasis Microcirculation TRPV1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Acetylcholine iontophoresis

Intervention Type OTHER

Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

Sodium Nitroprussiate iontophoresis

Intervention Type OTHER

Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

ppi water iontophoresis

Intervention Type OTHER

ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

Laser Doppler recording

Intervention Type OTHER

Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.

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.

Group Type EXPERIMENTAL

Acetylcholine iontophoresis

Intervention Type OTHER

Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

Sodium Nitroprussiate iontophoresis

Intervention Type OTHER

Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

ppi water iontophoresis

Intervention Type OTHER

ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

Laser Doppler recording

Intervention Type OTHER

Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.

Interventions

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Acetylcholine iontophoresis

Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT

Other Identifiers

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69HCL15_0425

Identifier Type: -

Identifier Source: org_study_id