PALLAS Laser for Skin Diseases (PALLAS-UV)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Atopic Dermatitis; Alopecia Areata; Vitiligo Vulgaris
• Intervention / Treatment: Device: UVB laser treatment

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lajos Kemény, professor, MD, DSc, MHAS; Phone Number: +36305152884; Email: kemeny.lajos@med.u-szeged.hu

Study Locations

• Hungary
  • Csongrád-Csanád Vármegye
    • Szeged, Csongrád-Csanád Vármegye, Hungary, 6720
      • Recruiting
      • University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
      • Contact: Lajos Kemény, professor, MD, DSc, MHAS; Phone Number: +36305152884; Email: kemeny.lajos@med.u-szeged.hu
      • Principal Investigator: Lajos Kemény, Professor, MD, DSc, MHAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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,
2. a skin condition that is expected to respond well to targeted UVB treatment,
3. a signed consent form.

Exclusion Criteria:

1. Patient under 18 years of age,
2. pregnancy
3. epilepsy,
4. fever, infectious diseases,
5. the patient is within one month or currently enrolled in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pallas Laser treated; UVB treated patients

Device: UVB laser treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/	maximum 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Maximum 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Score	At the last visit, the patient assesses the improvement: Patient satisfaction scale: 0 = extremely dissatisfied; = dissatisfied; = satisfied; = extremely satisfied	maximum 3 months

Collaborators and Investigators

• Sponsor: Szeged University

Publications and helpful links

General 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.
• Bonis 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.
• Baltas 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: atopic dermatitis; psoriasis; vitiligo; alopecia areata; UVB laser treatment; PALLAS laser
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Alopecia Areata; Vitiligo; Psoriasis; Dermatitis, Atopic
• Other Study ID Numbers: MD-PALL-01; CIV-HU-25-08-053914 (Other Identifier: National Centre for Public Health and Pharmacy, Budapest)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No