PALLAS Laser for Skin Diseases

NCT ID: NCT07250997

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-12-31

Brief 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).

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

Conditions

Vitiligo Vulgaris; Psoriasis; Alopecia Areata; Atopic Dermatitis

Study Design

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

Study Groups

Pallas Laser treated

UVB treated patients

Group Type: OTHER

UVB laser treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Szeged University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Kemény Lajos

Professor, MD, DSc, MHAS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology

Szeged, Csongrád-Csanád Vármegye, Hungary

Countries

Hungary

Central Contacts

Lajos Kemény, professor, MD, DSc, MHAS

Role: CONTACT

kemeny.lajos@med.u-szeged.hu

+36305152884

Facility Contacts

Lajos Kemény, professor, MD, DSc, MHAS

Role: primary

kemeny.lajos@med.u-szeged.hu

+36305152884

References

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.

Reference Type: BACKGROUND

PMID: 12472364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9388408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11422057 (View on PubMed)

Other Identifiers

MD-PALL-01

Identifier Type: -

Identifier Source: org_study_id

CIV-HU-25-08-053914

Identifier Type: OTHER

Identifier Source: secondary_id