ClinicalTrials.gg
CompletedNCT05079256LPA-01Updated Jan 22, 2025

Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

An interventional study of 595 nm Pulsed dye laser (Candela V-beam perfecta) in Psoriasis Vulgaris, sponsored by Nick van der Beek. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Nick van der Beek · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2024, 2 years 1 month ago, and no results have been posted to the registry.

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Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 69 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 65 studies in Psoriasis with a site in Netherlands — 5 open to participants now, 8 under way, 1 of them phase 3. Psoriasis · Netherlands.

Enrollment
49th of 50
22 · median 276
Started
2022
with 1 other
No phase
3 of 65
1 open now
Registered
58th of 65
by date

Among the 65 studies in Psoriasis with a site in Netherlands, this one is the 49th largest by enrollment of the 50 interventional ones that give a count, is one of 2 that started in 2022, is one of 3 with no phase, and was the 58th registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.

Browse Psoriasis studies →

Open to participants now

5 of the 65 studies in Psoriasis with a site in Netherlands are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 69 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Psoriasis Vulgaris

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04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Laser therapy

    595 nm Pulsed dye laser (PDL) therapy for psoriasis

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

Interventions

  • Device595 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.

06

What researchers measure

Primary outcomes

  1. Recovery ration

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

    Time frame: 6 months.

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. Clinical improvement

    Change in severity determined using a visual-analogue scale.

    Time frame: 6 months

07

Study locations

1 site
  • ZBC MultiCare
    Hilversum, Noord-Holland 1217AB, Netherlands
08

References and documents

Individual participant data

Plan to share: No — The data acquired during the investigation will be made available upon request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2022 to primary completion in Oct 2024, 22 months.

Of 115 non-industry interventional studies with no phase under Psoriasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 22 months is close to that.

Counting every sponsor, half of 134 studies reached it within 19 months; a quarter within 8 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2021
First posted
Oct 15, 2021
StartActual
Dec 9, 2022
Primary completionActual
Oct 12, 2024
CompletionActual
Oct 12, 2024
Last update
Jan 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05079256
Lead sponsor
Nick van der Beek
Responsible party
Nick van der Beek (Managing director, ZBC MultiCare) — Sponsor-investigator
First posted
Oct 15, 2021
Start date
Dec 9, 2022
Primary completion
Oct 12, 2024
Completion
Oct 12, 2024
Last update
Jan 22, 2025

Study contacts

Nick van der Beek, Ph.D
principal investigator · ZBC MultiCare

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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