Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

Psoriasis Clinical Trial

— MicroPso  

Official title:

Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652065
• Other study ID #: 69HCL15_0425
• Status: Completed
• Phase: N/A
• Start date: February 8, 2016
• Est. completion date: July 16, 2018

Study information

• Verified date: July 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Heat sensitivity	Heat sensitivity will be assessed using hot (50°C) and cold (4°C) water	at the latest 3 months after inclusion