Clinical trial NCT05079256: Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin
Official title: A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Lead sponsor: ZBC MultiCare
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2021-10-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: single blinded intra-patient comparison
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recovery ration
timeFrame: 6 months.
Secondary outcomes:
measure: Recovery ratio vs lymphocyte infiltration
timeFrame: 6 months
measure: Clinical improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Hilversum
country: Netherlands
facility: ZBC MultiCare
state: Noord-Holland
Study officials:
affiliation: ZBC MultiCare
name: Nick van der Beek, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: