Vitiligo VulgarisPALLAS-UVNCT07250997
PALLAS Laser for Skin Diseases
A study testing UVB laser treatment in people with Vitiligo Vulgaris and Psoriasis, run by Szeged University at 1 site in Hungary.
Trial summary
The primary objective of this study is to get clinical experiences with the PALLAS laser in the treatment of skin conditions that respond well to UV light (vitiligo, psoriasis, alopecia areata, atopic dermatitis). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo Vulgaris, Psoriasis, Alopecia Areata
- What is being tested?
- UVB laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 10 Dec 2025to 31 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject understands the information provided, gives informed consent to participate in the study and is deemed by the investigator to be able to participate,
- a skin condition that is expected to respond well to targeted UVB treatment,
- a signed consent form.
Who cannot join
- Patient under 18 years of age,
- pregnancy
- epilepsy,
- fever, infectious diseases,
- the patient is within one month or currently enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
Szeged, Csongrád-Csanád Vármegye, 6720
Lajos Kemény, professor, MD, DSc, MHAS, +36305152884, kemeny.lajos@med.u-szeged.hu
Lajos Kemény, professor, MD, DSc, MHAS
About this study
Official title: Study of the Effectiveness of the PALLAS Laser in the Treatment of Skin Diseases That Respond Well to UV Light
The primary objective of this study is to get clinical experiences with the PALLAS laser in the treatment of skin conditions that respond well to UV light (vitiligo, psoriasis, alopecia areata, atopic dermatitis).
The secondary objective is to assess how user-friendly is the Pallas laser in the treatment of skin diseases.
Read more
The patient in the trial will receive UVB laser treatment (2 treatments per week for up to 3 months). The treatments will be carried out by the doctors participating in the trial.
The treatment takes approximately 10 minutes per session, and can last up to 3 months per patient.
Photographic documentation of the lesions to be treated and the lesions treated is taken at the start of the examination and then once a month.
At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.
Read the detailed description
This clinical study is a prospective testing and assessment of a CE marked PALLAS laser device within its intended use, carried out in one centre.
PALLAS is a solid-state ultraviolet laser system with 311 nm emission wavelength for tissue incision, destruction and removal.
The laser is intended for use on different parts of the skin, typically the face, hands, arms, feet or legs.
Pallas eliminates the shortcomings of currently used excimer lasers, such as the instability of the emitted energy and the expensive maintenance costs. The energy emitted by the laser is stable over a long period of time, maximising the effectiveness of the treatments and minimising the potential side effects of skin burns.
EUDAMED registration
LASEROPTEK sheet with SRN number:
https://ec.europa.eu/tools/eudamed/#/screen/search-eo/61c45e80-9297-4dcd-8940-8f7ccad5ef22 Actor ID/SRN: KR-MF-000018426
- Conditions
- Vitiligo Vulgaris, Psoriasis, Alopecia Areata, Atopic Dermatitis
- Being tested
- UVB laser treatment
- Keywords
- UVB laser treatment, PALLAS laser, vitiligo, psoriasis, alopecia areata, atopic dermatitis
- Medical subject headings
- Vitiligo, Psoriasis, Alopecia Areata, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVB laser treatmentDevice
In clinical practice, 311 nm ultraviolet B (UVB) phototherapy is often used to treat various skin conditions. In 1996, the 308 nm xenon chloride excimer laser was developed for the treatment of psoriasis. In the last decades, excimer treatment has been incorporated into international therapeutic protocols for the treatment of psoriasis alongside conventional 311 nm UVB therapies. In the present study, the investigators aim to gain experience with a UVB laser (Pallas) operating at a wavelength of 311 nm. The CE-marked Pallas UVB laser will be used for the same indications as the 308 nm excimer laser. The procedure is not new, but the significance of this study lies in its potential to provide us with experience using this device for targeted UVB treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pallas Laser treated | Other | UVB treated patients Receives: Device: UVB laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: visible improvement of the treated skin disease.
Vitiligo (VES score): https://www.vitiligo-calculator.com/ Psoriasis (PASI-score): https://pasi.corti.li/ Alopecia areata (SALT score) https://dermatopics.dk/salt-score/ Atopiás dermatitis (EASI score): https://www.easiderm.com/
Measured: maximum 3 months
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a 10-question, self-administered survey that assesses how skin diseases affect a patient's health-related quality of life.
Measured: Maximum 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitiligo 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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Kemény Lajos, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250997
- Sponsor's protocol ID
- MD-PALL-01
- Other IDs
- CIV-HU-25-08-053914
- Acronym
- PALLAS-UV
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baltas E, Csoma Z, Ignacz F, Dobozy A, Kemeny L. Treatment of vitiligo with the 308-nm xenon chloride excimer laser. Arch Dermatol. 2002 Dec;138(12):1619-20. No abstract available.
PubMed 12472364Bonis B, Kemeny L, Dobozy A, Bor Z, Szabo G, Ignacz F. 308 nm UVB excimer laser for psoriasis. Lancet. 1997 Nov 22;350(9090):1522. doi: 10.1016/S0140-6736(05)63945-1. No abstract available.
PubMed 9388408Baltas E, Nagy P, Bonis B, Novak Z, Ignacz F, Szabo G, Bor Z, Dobozy A, Kemeny L. Repigmentation of localized vitiligo with the xenon chloride laser. Br J Dermatol. 2001 Jun;144(6):1266-7. doi: 10.1046/j.1365-2133.2001.04248.x. No abstract available.
PubMed 11422057
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of the PALLAS Laser in the Treatment of Skin Diseases That Respond Well to UV Light
- ClinicalTrials.gov ID
- NCT07250997
- Acronym / sponsor ID
- PALLAS-UV / MD-PALL-01
- Conditions
- Vitiligo Vulgaris, Psoriasis, Alopecia Areata, Atopic Dermatitis
- Keywords
- UVB laser treatment, PALLAS laser, vitiligo, psoriasis, alopecia areata, atopic dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 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.
The primary objective of this study is to get clinical experiences with the PALLAS laser in the treatment of skin conditions that respond well to UV light (vitiligo, psoriasis, alopecia areata, atopic dermatitis).
The secondary objective is to assess how user-friendly is the Pallas laser in the treatment of skin diseases.
The patient in the trial will receive UVB laser treatment (2 treatments per week for up to 3 months). The treatments will be carried out by the doctors participating in the trial.
The treatment takes approximately 10 minutes per session, and can last up to 3 months per patient.
Photographic documentation of the lesions to be treated and the lesions treated is taken at the start of the examination and then once a month.
At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.
Detailed description
This clinical study is a prospective testing and assessment of a CE marked PALLAS laser device within its intended use, carried out in one centre.
PALLAS is a solid-state ultraviolet laser system with 311 nm emission wavelength for tissue incision, destruction and removal.
The laser is intended for use on different parts of the skin, typically the face, hands, arms, feet or legs.
Pallas eliminates the shortcomings of currently used excimer lasers, such as the instability of the emitted energy and the expensive maintenance costs. The energy emitted by the laser is stable over a long period of time, maximising the effectiveness of the treatments and minimising the potential side effects of skin burns.
EUDAMED registration
LASEROPTEK sheet with SRN number:
https://ec.europa.eu/tools/eudamed/#/screen/search-eo/61c45e80-9297-4dcd-8940-8f7ccad5ef22 Actor ID/SRN: KR-MF-000018426
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pallas Laser treated | Other | Device: UVB laser treatmentUVB treated patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject understands the information provided, gives informed consent to participate in the study and is deemed by the investigator to be able to participate,
- a skin condition that is expected to respond well to targeted UVB treatment,
- a signed consent form.
Key exclusion criteria (5 listed)
- Patient under 18 years of age,
- pregnancy
- epilepsy,
- fever, infectious diseases,
- the patient is within one month or currently enrolled in another clinical trial.
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 |
|---|---|---|
| UVB laser treatmentIn clinical practice, 311 nm ultraviolet B (UVB) phototherapy is often used to treat various skin conditions. In 1996, the 308 nm xenon chloride excimer laser was developed for the treatment of psoriasis. In the last decades, excimer treatment has been incorporated into international therapeutic protocols for the treatment of psoriasis alongside conventional 311 nm UVB therapies. In the present study, the investigators aim to gain experience with a UVB laser (Pallas) operating at a wavelength of 311 nm. The CE-marked Pallas UVB laser will be used for the same indications as the 308 nm excimer laser. The procedure is not new, but the significance of this study lies in its potential to provide us with experience using this device for targeted UVB treatment. | Device | Pallas Laser treated |
Primary outcome
Primary Endpoint: visible improvement of the treated skin disease.
Time frame: maximum 3 months
Vitiligo (VES score): https://www.vitiligo-calculator.com/ Psoriasis (PASI-score): https://pasi.corti.li/ Alopecia areata (SALT score) https://dermatopics.dk/salt-score/ Atopiás dermatitis (EASI score): https://www.easiderm.com/
1 secondary outcome
Dermatology Life Quality Index (DLQI)
Time frame: Maximum 3 months
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 6 Feb 2026.
- Background: PubMed 12472364Baltas E, Csoma Z, Ignacz F, Dobozy A, Kemeny L. Treatment of vitiligo with the 308-nm xenon chloride excimer laser. Arch Dermatol. 2002 Dec;138(12):1619-20. No abstract available.
- Background: PubMed 9388408Bonis B, Kemeny L, Dobozy A, Bor Z, Szabo G, Ignacz F. 308 nm UVB excimer laser for psoriasis. Lancet. 1997 Nov 22;350(9090):1522. doi: 10.1016/S0140-6736(05)63945-1. No abstract available.
- Background: PubMed 11422057Baltas E, Nagy P, Bonis B, Novak Z, Ignacz F, Szabo G, Bor Z, Dobozy A, Kemeny L. Repigmentation of localized vitiligo with the xenon chloride laser. Br J Dermatol. 2001 Jun;144(6):1266-7. doi: 10.1046/j.1365-2133.2001.04248.x. No abstract available.
- Individual participant dataSharing planned: No
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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 UVB laser treatment in people with Vitiligo Vulgaris and Psoriasis, run by Szeged University at 1 site in Hungary.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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 Hungary. 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 Lajos Kemény, professor, MD, DSc, MHAS (+36305152884, kemeny.lajos@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: visible improvement of the treated skin disease. (time frame: maximum 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250997, which also lists 3 linked publications.
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 6 Feb 2026.