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Not yet recruitingNCT07130019Updated Aug 19, 2025

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

An interventional study of Fluorescence guided thermal ablation of epidermal tissue and Thermal ablation of epidermal tissue in Psoriasis, sponsored by Nick van der Beek. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by Nick van der Beek · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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). 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.

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.

02

Conditions studied

  • Psoriasis

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Keywords

  • psoriasis
  • lasertherapy
  • fluorescence
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 47 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Nick van der Beek is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Fluorescence controlled ablation

    Fluorescence guided thermal tissue ablation

    Procedure: Fluorescence guided thermal ablation of epidermal tissue

  • Active comparator
    Classic tissue ablation

    Thermal tissue ablation a vue

    Procedure: Thermal ablation of epidermal tissue

  • No intervention
    Control

Interventions

  • ProcedureFluorescence guided thermal ablation of epidermal tissue

    Thermal ablation of epidermal tissue under fluorescence control.

  • ProcedureThermal ablation of epidermal tissue

    Thermal ablation of skin tissue a vue

06

What researchers measure

Primary outcomes

  1. PGA

    PGA value (0 - 7)

    Time frame: 8 weeks

  2. Remission

    Remission score (0,1)

    Time frame: 8 weeks

Secondary outcomes

  1. Healing time

    Healing time in weeks

    Time frame: 8 weeks

07

Study locations

1 site
  • ZBC Multicare
    Hilversum, North Holland 1217AB, Netherlands
    • Nick van der Beek, Ph.D, LL.M, M.Sc · Contact · info@zbcmulticare.nl · +31356249576
    • Nick van der Beek, Ph.D, LL.M, M.Sc · Principal investigator
    • M.E. Schram, Ph.D., M.D. · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — PGA Remission

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07130019
Lead sponsor
Nick van der Beek
Responsible party
Nick van der Beek (General manager, ZBC MultiCare) — Sponsor-investigator
First posted
Aug 19, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Aug 19, 2025

Study contacts

Nick van der Beek, PhD, LL.M, M.Sc
Contact
info@zbcmulticare.nl
+31356249576

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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