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Completed

NCT Number: NCT05079256

Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

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.

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Key information

Conditions

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZBC MultiCare

Hilversum, North Holland, 1217AB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Recovery ration

    Time frame: 6 months.

    Relative change in the ratio of the linear nerve density and linear blood vessel density.

Secondary outcomes

  1. Recovery ratio vs lymphocyte infiltration

    Time frame: 6 months

    Correlation between change in the ratio of the linear nerve density and linear blood vessel density versus change in number of infiltrating lymphocytes

  2. Clinical improvement

    Time frame: 6 months

    Change in severity determined using a visual-analogue scale.

Sponsors and collaborators

Lead sponsor

Nick van der Beek

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LPA-01

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2021
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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