PALLAS Laser for Skin Diseases (PALLAS-UV)

University of Szeged (SZTE)

Status: Enrolling

Conditions: Atopic Dermatitis; Psoriasis; Vitiligo Vulgaris; Alopecia Areata

Treatments: Device: UVB laser treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07250997

CIV-HU-25-08-053914 (Other Identifier)

MD-PALL-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Pallas Laser treated

Other group

Description:

UVB treated patients

Treatment:

Device: UVB laser treatment