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PsoriasisNCT07130019

Is Monitoring Enhanced Auto-fluorescence Beneficial for the Precise Removal of Tissue From Psoriatic Lesions With Ablative Lasers?

A study testing Fluorescence guided thermal ablation of epidermal tissue and Thermal ablation of epidermal tissue in people with Psoriasis, run by Nick van der Beek at 1 site in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

It is known that psoriatic lesions clear and remain cleared if you remove them from the skin. This can be done through surgery and ablative laser therapy. In order for the treatment to be succesful, you need to remove the complete epidermis and a bit of the dermis (the upper part of the skin). Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Psoriasis
What is being tested?
Fluorescence guided thermal ablation of epidermal tissue and Thermal ablation of epidermal tissue
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteNetherlands
Study dates
1 Sep 2025to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of psoriasis vulgaris of any severity with at least three discrete lesions in optically non-obscured skin located on torso, abdomen, dorsum, legs, arms, face or buttocks.

Who cannot join

  • Pregnancy or breastfeeding.
  • Rheumatoid and psoriatic arthritis
  • Fitzpatrick skin type >4.
  • Known allergy to 5-aminolevulinic acid (5-ALA) or light sensitivity.
  • Autoimmune disorders.
  • Heavy smoking.
Show all 17Show fewer
  • Diabetes mellitus type 2
  • Active bacterial or viral infections in the treatment area
  • Recent use of isotretinoin
  • Morbid obesity
  • History of hypertrophic scaring or keloids
  • History of complicated wound healing
  • Body dysmorphic disorder
  • Use of anti-coagulants
  • Use of cyclosporin A or similar immunosuppressive medication
  • Increase in disease severity during the preceding 8 weeks.
  • If treatment area is on the legs: Severe venous insufficiency, severe lymphoedema or angiopathy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nick van der Beek, PhD, LL.M, M.Sc contact

+31356249576

info@zbcmulticare.nl

Netherlands1 site
  • ZBC Multicare

    Hilversum, North Holland, 1217AB

    Nick van der Beek, Ph.D, LL.M, M.Sc, +31356249576, info@zbcmulticare.nl

    Nick van der Beek, Ph.D, LL.M, M.Sc

Other trials in Netherlands

About this study

Official title: Autofluorescence-Guided Removal of Psoriatic Tissue

It is known that psoriatic lesions clear and remain cleared if you remove them from the skin. This can be done through surgery and ablative laser therapy. In order for the treatment to be succesful, you need to remove the complete epidermis and a bit of the dermis (the upper part of the skin). In psoriasis, the thickness of that part of the skin can vary significantly. Incomplete removal results in the return of the lesion. A challenge is that you can't easily tell how deep into the skin you are. Not only is the skin quite thin (from 0.1 mm to 1.0 mm), at the boundary they look quite similar. If you go too deep, you get scarring. Thus there is a need to delineate the psoriatic tissue from the healthy tissue.

We think that one way to do that is by looking at the fluorescence of the skin. If you shine a particular shade of blue light on the skin, it gives off red light. But this is only true for the part where the psoriasis can reside. Under normal circumstances this fluorescence is too weak to really see with the eye. Thus we first increase the fluorescence by administering a compound that is used to make the fluorescent molecules in our tissue, 5-aminolevulinic acid (5-ALA). It can be quite difficult to get 5-ALA into the skin. To help the 5-ALA, we use a very superficial lasertreatment to poke minute holes in the skin. The 5-ALA enters the skin and the fluorescence builds up. After a couple of hours, the skin is treated with a laser that can gently remove the tissue. Layer for layer is removed until there is no more fluorescence. At that point we do one more pass to be sure, and then stop. We hope that two months later, the psoriasis is gone and will remain so for at least a year.

Read more

We think that the fluorescence helps, but we can't be sure. So for that reason we will also treat a lesion without fluorescence and use the standard method to judge how deep we have treated the skin. And to rule out the possibility that e.g. sun exposure cleared the lesions, we also leave one lesion untreated.

Participants have to travel to the clinic for the treatment and then every three to five days for two weeks. Since we remove the skin, there will be a wound that needs healing and attending to. This will result in some limitations during the wound healing phase. Afterwards, you might see some temporary shifts in pigmentation.

Conditions
Psoriasis
Being tested
Fluorescence guided thermal ablation of epidermal tissue, Thermal ablation of epidermal tissue
Keywords
psoriasis, lasertherapy, fluorescence
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluorescence guided thermal ablation of epidermal tissueProcedure or surgery

    Thermal ablation of epidermal tissue under fluorescence control.

  • Thermal ablation of epidermal tissueProcedure or surgery

    Thermal ablation of skin tissue a vue

Study groups in NCT07130019
Study groupRoleWhat they receive
Fluorescence controlled ablationExperimentalFluorescence guided thermal tissue ablation
Receives: Procedure: Fluorescence guided thermal ablation of epidermal tissue
Classic tissue ablationActive comparatorThermal tissue ablation a vue
Receives: Procedure: Thermal ablation of epidermal tissue
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PGA

    PGA value (0 - 7)

    Measured: 8 weeks

  2. Remission

    Remission score (0,1)

    Measured: 8 weeks

Secondary outcomes (1)
  1. Healing time

    Healing time in weeks

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130019
Sponsor's protocol ID
LPA-2
Status last verified
May 2025
First submitted
11 Aug 2025
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: PGA Remission

Questions about this trial

What is this clinical trial studying?

A study testing Fluorescence guided thermal ablation of epidermal tissue and Thermal ablation of epidermal tissue in people with Psoriasis, 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 1 inclusion and 17 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: opening soon, as of the sponsor's last update on 19 Aug 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nick van der Beek, PhD, LL.M, M.Sc (+31356249576, info@zbcmulticare.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PGA (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 19 Aug 2025.

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