Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin (LPA-01)
Primary Purpose
Psoriasis Vulgaris
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
595 nm Pulsed dye laser (Candela V-beam perfecta)
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
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
Sites / Locations
- ZBC MultiCareRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser therapy
Arm Description
595 nm Pulsed dye laser (PDL) therapy for psoriasis
Outcomes
Primary Outcome Measures
Recovery ration
Relative change in the ratio of the linear nerve density and linear blood vessel density.
Secondary Outcome Measures
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
Clinical improvement
Change in severity determined using a visual-analogue scale.
Full Information
NCT ID
NCT05079256
First Posted
September 20, 2021
Last Updated
January 23, 2023
Sponsor
Nick van der Beek
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05079256
Brief Title
Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin
Acronym
LPA-01
Official Title
A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
December 9, 2023 (Anticipated)
Study Completion Date
February 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nick van der Beek
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
single blinded intra-patient comparison
Masking
None (Open Label)
Masking Description
tissue samples are described using random pre-assigned codes.
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser therapy
Arm Type
Experimental
Arm Description
595 nm Pulsed dye laser (PDL) therapy for psoriasis
Intervention Type
Device
Intervention Name(s)
595 nm Pulsed dye laser (Candela V-beam perfecta)
Intervention Description
595 nm pulsed dye laser therapy. 2 treatments Fluence ~ 6 - 9 J/cm^2 Pulse duration ~ 0.45 - 3.0 ms 33% overlap.
Primary Outcome Measure Information:
Title
Recovery ration
Description
Relative change in the ratio of the linear nerve density and linear blood vessel density.
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Recovery ratio vs lymphocyte infiltration
Description
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
Title
Clinical improvement
Description
Change in severity determined using a visual-analogue scale.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nick van der Beek, Ph.D
Phone
+31356249576
Email
Clinical_Research@zbcmulticare.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick van der Beek, Ph.D
Organizational Affiliation
ZBC MultiCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZBC MultiCare
City
Hilversum
State/Province
Noord-Holland
ZIP/Postal Code
1217AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick van der Beek, Ph.D.
Phone
+31356249576
Email
Clinical_Research@zbcmulticare.nl
First Name & Middle Initial & Last Name & Degree
Nick van der Beek, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data acquired during the investigation will be made available upon request.
Links:
URL
https://zbcmulticare.nl/lasering-psoriasis-away/
Description
This investigation is part of a larger research collaboration, more information on which can be found at the website mentioned above.
Learn more about this trial
Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin
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