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.
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.
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
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 group | Role | What they receive |
|---|---|---|
| Fluorescence controlled ablation | Experimental | Fluorescence guided thermal tissue ablation Receives: Procedure: Fluorescence guided thermal ablation of epidermal tissue |
| Classic tissue ablation | Active comparator | Thermal tissue ablation a vue Receives: Procedure: Thermal ablation of epidermal tissue |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGA
PGA value (0 - 7)
Measured: 8 weeks
Remission
Remission score (0,1)
Measured: 8 weeks
Secondary outcomes (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.
- First posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
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
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autofluorescence-Guided Removal of Psoriatic Tissue
- ClinicalTrials.gov ID
- NCT07130019
- Acronym / sponsor ID
- LPA-2
- Conditions
- Psoriasis
- Keywords
- psoriasis, lasertherapy, fluorescence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Nick van der BeekUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Aug 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluorescence controlled ablation | Experimental | Procedure: Fluorescence guided thermal ablation of epidermal tissueFluorescence guided thermal tissue ablation |
| Classic tissue ablation | Active comparator | Procedure: Thermal ablation of epidermal tissueThermal tissue ablation a vue |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- Pregnancy or breastfeeding.
- Rheumatoid and psoriatic arthritis
- Fitzpatrick skin type >4.
- Known allergy to 5-aminolevulinic acid (5-ALA) or light sensitivity.
- Autoimmune disorders.
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 |
|---|---|---|
| Fluorescence guided thermal ablation of epidermal tissueThermal ablation of epidermal tissue under fluorescence control. | Procedure or surgery | Fluorescence controlled ablation |
| Thermal ablation of epidermal tissueThermal ablation of skin tissue a vue | Procedure or surgery | Classic tissue ablation |
Primary outcome
PGA
Time frame: 8 weeks
PGA value (0 - 7)
Remission
Time frame: 8 weeks
Remission score (0,1)
1 secondary outcome
Healing time
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. PGA Remission
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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.
1 site in 1 country: see every site and its status.
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.