Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin (LPA-01)

A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions

The researchers investigate the effect of a treatment with selective photothermolysis using a 595 nm pulsed dye laser on the blood vessel density and the nerve fibre density of a psoriatic lesion. By comparing tissue samples collected before and after two treatments, the researchers determine the relative effect of laser therapy on the (hyper)innervation of psoriatic skin.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)

Detailed Description

Vascular laser therapy for psoriasis seems to achieve a remarkably long treatment-free duration of remission. But why would sub-second heating of the blood vessels of the skin result in a year-long resolution of an infamously stubborn condition?

Unraveling the mechanism of action of laser therapy would not only allow for the improvement of existing laser therapy protocols but also, could open the door to a whole new range of interventions offering quasi-permanent solutions for patients. There is a high need for such enduring therapies: Psoriasis is both, a common and a costly skin condition. It affects between 1% and 9% of the population and has a very severe impact on the quality of life of the patient. It's chronic character implies lifelong treatment, and the associated risks and effort

This project aims to assess the effect of laser therapy on the blood vessels and (peripheral) innervation of psoriasis plaques. The primary objective is to quantify the regression and recovery of nerves compared to blood vessels. The researchers hypothesize that the recovery of nerves after Selective Photo Thermolysis (SPT) is decreased compared to the recovery of blood vessels.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick van der Beek, Ph.D; Phone Number: +31356249576; Email: Clinical_Research@zbcmulticare.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Hilversum, Noord-Holland, Netherlands, 1217AB
      • ZBC MultiCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 - 69 years of age
• Psoriasis vulgaris
• Skin type I - III
• Minimal surface of lesion of 3 cm2
• Contralateral psoriasis vulgaris lesions located on chest, back, or upper legs

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study if:

• The participant uses other treatments (than laser therapy) during the study or two weeks before the start of the study that are known to affect psoriasis
• The participant suffers from any known neurological, vascular, or immunological condition other than psoriasis.
• The participant is allergic to lidocaine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser therapy; 595 nm Pulsed dye laser (PDL) therapy for psoriasis	Device: 595 nm Pulsed dye laser (Candela V-beam perfecta); 595 nm pulsed dye laser therapy. 2 treatments Fluence ~ 6 - 9 J/cm^2 Pulse duration ~ 0.45 - 3.0 ms 33% overlap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery ration	Relative change in the ratio of the linear nerve density and linear blood vessel density.	6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery ratio vs lymphocyte infiltration	Correlation between change in the ratio of the linear nerve density and linear blood vessel density versus change in number of infiltrating lymphocytes	6 months
Clinical improvement	Change in severity determined using a visual-analogue scale.	6 months

Collaborators and Investigators

• Sponsor: Nick van der Beek
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Nick van der Beek, Ph.D, ZBC MultiCare

Publications and helpful links

Helpful Links

• This investigation is part of a larger research collaboration, more information on which can be found at the website mentioned above.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Diseases, Papulosquamous; Metaplasia; Psoriasis; Neovascularization, Pathologic
• Other Study ID Numbers: LPA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data acquired during the investigation will be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes