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Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis (MicroPso)

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acetylcholine iontophoresis
Sodium Nitroprussiate iontophoresis
ppi water iontophoresis
Laser Doppler recording
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring Psoriasis, Microcirculation, TRPV1

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy skin

Psoriasis plaque

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sensory detection threshold
Increasing size of Von Frey filaments will be placed onto patients' skin to assess sensory detection threshold.
Potential discomfort sensation thresholds
Increasing size of Von Frey filaments will be placed onto patients' skin to assess potential discomfort sensation threshold.
Heat sensitivity
Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water

Full Information

First Posted
January 7, 2016
Last Updated
July 10, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02652065
Brief Title
Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
Acronym
MicroPso
Official Title
Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2016 (Actual)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Microcirculation, TRPV1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy skin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Psoriasis plaque
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acetylcholine iontophoresis
Intervention Description
Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
Intervention Type
Other
Intervention Name(s)
Sodium Nitroprussiate iontophoresis
Intervention Description
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
Intervention Name(s)
ppi water iontophoresis
Intervention Description
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
Intervention Name(s)
Laser Doppler recording
Intervention Description
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 Measure Information:
Title
skin blood flow variation
Description
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.
Time Frame
at the latest 3 months after inclusion
Secondary Outcome Measure Information:
Title
Sensory detection threshold
Description
Increasing size of Von Frey filaments will be placed onto patients' skin to assess sensory detection threshold.
Time Frame
at the latest 3 months after inclusion
Title
Potential discomfort sensation thresholds
Description
Increasing size of Von Frey filaments will be placed onto patients' skin to assess potential discomfort sensation threshold.
Time Frame
at the latest 3 months after inclusion
Title
Heat sensitivity
Description
Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water
Time Frame
at the latest 3 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie
City
LYON cedex 03
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

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