Laser Induced Changes to Innervation and Vascularisation... | NCT05079256

Studies
Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

NCT05079256

Sponsor

Nick van der Beek

Status

Completed

Last Update Posted

Jan 22, 2025Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Psoriasis Vulgaris

Interventions

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

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2022Actual

Primary Completion Date

Oct 12, 2024Actual

Completion Date

Oct 12, 2024Actual

First Submitted Date

Sep 20, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nick van der Beek, Managing director, ZBC MultiCareSponsor-Investigator

Lead Sponsor

Nick van der BeekOTHER

Collaborators

Name	Class
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser therapy	Experimental	595 nm Pulsed dye laser (PDL) therapy for psoriasis	Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Laser therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nick van der Beek, Ph.D	ZBC MultiCare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ZBC MultiCare		Hilversum	North Holland	1217AB	Netherlands

References Module

Citations

Not provided

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies