LPA-01: Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

• Sponsor: Nick van der Beek (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05079256
• Collaborator: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Enrollment: 25
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: single blinded intra-patient comparisonsingle blinded intra-patient comparison
• Masking: Single (Outcomes Assessor)
• Masking Description: tissue samples are described using random pre-assigned codes.
• Primary Purpose: Treatment
• Official Title: A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions
• Anticipated Study Start Date: Jun 21, 2022
• Anticipated Primary Completion Date: Mar 21, 2023
• Anticipated Study Completion Date: Mar 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser therapy 595 nm Pulsed dye laser (PDL) therapy for psoriasis	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.
No Intervention: deferred treatment Untreated lesion

Outcome Measures

Primary Outcome Measures

1. Recovery ration [6 months.]

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

Secondary Outcome Measures

1. Recovery ratio vs lymphocyte infiltration [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 [6 months]

   Change in severity determined using a visual-analogue scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ZBC MultiCare	Hilversum	Noord-Holland	Netherlands	1217AB

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Nick van der Beek, Ph.D, ZBC MultiCare

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Nick van der Beek, Managing director, ZBC MultiCare
• ClinicalTrials.gov Identifier: NCT05079256
• Other Study ID Numbers: LPA-01
• First Posted: Oct 15, 2021
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Psoriasis; Neovascularization, Pathologic

Study Results

No Results Posted as of Jun 2, 2022