Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

NCT ID: NCT05079256

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-09
• Study Completion Date: 2024-10-12

Brief Summary

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.

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.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser therapy

595 nm Pulsed dye laser (PDL) therapy for psoriasis

Group Type: EXPERIMENTAL

595 nm Pulsed dye laser (Candela V-beam perfecta)

Intervention Type: DEVICE

595 nm pulsed dye laser therapy. 2 treatments Fluence \~ 6 - 9 J/cm\^2 Pulse duration \~ 0.45 - 3.0 ms 33% overlap.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Nick van der Beek

OTHER

Sponsor Role: lead

Responsible Party

Nick van der Beek

Managing director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nick van der Beek, Ph.D

Role: PRINCIPAL_INVESTIGATOR

ZBC MultiCare

Locations

ZBC MultiCare

Hilversum, North Holland, Netherlands

Countries

Netherlands

Related Links

https://zbcmulticare.nl/lasering-psoriasis-away/

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

Other Identifiers

LPA-01

Identifier Type: -

Identifier Source: org_study_id