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

NCT ID: NCT07130019

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-01

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluorescence controlled ablation

Fluorescence guided thermal tissue ablation

Group Type: EXPERIMENTAL

Fluorescence guided thermal ablation of epidermal tissue

Intervention Type: PROCEDURE

Thermal ablation of epidermal tissue under fluorescence control.

Classic tissue ablation

Thermal tissue ablation a vue

Group Type: ACTIVE_COMPARATOR

Thermal ablation of epidermal tissue

Intervention Type: PROCEDURE

Thermal ablation of skin tissue a vue

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluorescence guided thermal ablation of epidermal tissue

Thermal ablation of epidermal tissue under fluorescence control.

Intervention Type: PROCEDURE

Thermal ablation of epidermal tissue

Thermal ablation of skin tissue a vue

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nick van der Beek

OTHER

Sponsor Role: lead

Responsible Party

Nick van der Beek

General manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

ZBC Multicare

Hilversum, North Holland, Netherlands

Countries

Netherlands

Central Contacts

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

Role: CONTACT

info@zbcmulticare.nl

+31356249576

Facility Contacts

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

Role: primary

info@zbcmulticare.nl

+31356249576

Other Identifiers

LPA-2

Identifier Type: -

Identifier Source: org_study_id