NCT02652065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

February 8, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

January 7, 2016

Last Update Submit

December 13, 2025

Conditions

Keywords

PsoriasisMicrocirculationTRPV1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sensory detection threshold

    at the latest 3 months after inclusion

  • Potential discomfort sensation thresholds

    at the latest 3 months after inclusion

  • Heat sensitivity

    at the latest 3 months after inclusion

Study Arms (2)

Healthy skin

ACTIVE COMPARATOR

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 iontophoresisOther: Sodium Nitroprussiate iontophoresisOther: ppi water iontophoresisOther: Laser Doppler recording

Psoriasis plaque

EXPERIMENTAL

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 iontophoresisOther: Sodium Nitroprussiate iontophoresisOther: ppi water iontophoresisOther: Laser Doppler recording

Interventions

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

Healthy skinPsoriasis plaque

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

Healthy skinPsoriasis plaque

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

Healthy skinPsoriasis plaque

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

Healthy skinPsoriasis plaque

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie

Lyon, 69437, France

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

February 8, 2016

Primary Completion

July 16, 2018

Study Completion

July 16, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations