Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

Psoriasis Vulgaris Clinical Trial

— LPA-01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05079256
• Other study ID #: LPA-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: ZBC MultiCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Psoriasis
• Psoriasis Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Netherlands	ZBC MultiCare	Hilversum	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Nick van der Beek	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery ration	Relative change in the ratio of the linear nerve density and linear blood vessel density.	6 months.
Secondary	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
Secondary	Clinical improvement	Change in severity determined using a visual-analogue scale.	6 months

External Links

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