Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 69 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05079256
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nick van der Beek
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nick van der Beek, Ph.D
Principal Investigator Affiliation ZBC MultiCare
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Laser therapy

595 nm Pulsed dye laser (PDL) therapy for psoriasis

No Intervention: deferred treatment

Untreated lesion

Interventions

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.

Contact a Trial Team

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International Sites

ZBC MultiCare, Hilversum, Noord-Holland, Netherlands

Status

Address

ZBC MultiCare

Hilversum, Noord-Holland, 1217AB

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