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Trial record 31 of 1714 for:    psoriasis

Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis (MicroPso)

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ClinicalTrials.gov Identifier: NCT02652065
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Psoriasis Other: Acetylcholine iontophoresis Other: Sodium Nitroprussiate iontophoresis Other: ppi water iontophoresis Other: Laser Doppler recording Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
Actual Study Start Date : February 8, 2016
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : July 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Psoriasis

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sensory detection threshold [ Time Frame: at the latest 3 months after inclusion ]
    Increasing size of Von Frey filaments will be placed onto patients' skin to assess sensory detection threshold.

  2. Potential discomfort sensation thresholds [ Time Frame: 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.

  3. Heat sensitivity [ Time Frame: at the latest 3 months after inclusion ]
    Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652065


Locations
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France
Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie
LYON cedex 03, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02652065     History of Changes
Other Study ID Numbers: 69HCL15_0425
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Psoriasis
Microcirculation
TRPV1
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Acetylcholine
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs