Psoriasis VulgarisLPA-01NCT05079256
Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin
A study testing 595 nm Pulsed dye laser (Candela V-beam perfecta) in people with Psoriasis Vulgaris, run by Nick van der Beek at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- 595 nm Pulsed dye laser (Candela V-beam perfecta)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Dec 2022to 12 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- 595 nm Pulsed dye laser (Candela V-beam perfecta)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | 595 nm Pulsed dye laser (PDL) therapy for psoriasis Receives: Device: 595 nm Pulsed dye laser (Candela V-beam perfecta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery ration
Relative change in the ratio of the linear nerve density and linear blood vessel density.
Measured: 6 months.
Secondary outcomes (2)
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
Measured: 6 months
Clinical improvement
Change in severity determined using a visual-analogue scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start9 Dec 2022
- Primary completion12 Oct 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- single blinded intra-patient comparison
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nick van der Beek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nick van der Beek, ZBC MultiCare
- Investigators
- Nick van der Beek, Ph.D, Principal investigator, ZBC MultiCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079256
- Sponsor's protocol ID
- LPA-01
- Acronym
- LPA-01
- Status last verified
- Jan 2025
- First submitted
- 20 Sep 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data acquired during the investigation will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions
- ClinicalTrials.gov ID
- NCT05079256
- Acronym / sponsor ID
- LPA-01 / LPA-01
- Conditions
- Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nick van der BeekUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 12 Oct 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single blinded intra-patient comparison
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)595 nm Pulsed dye laser (PDL) therapy for psoriasis |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Laser therapy |
Primary outcome
Recovery ration
Time frame: 6 months.
Relative change in the ratio of the linear nerve density and linear blood vessel density.
2 secondary outcomes
Recovery ratio vs lymphocyte infiltration
Time frame: 6 months
Clinical improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- This investigation is part of a larger research collaboration, more information on which can be found at the website mentioned above.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The data acquired during the investigation will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick van der Beek, Ph.D principal investigator
ZBC MultiCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 595 nm Pulsed dye laser (Candela V-beam perfecta) in people with Psoriasis Vulgaris, run by Nick van der Beek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery ration (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.