PALLAS Laser for Skin Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UVB laser treatment.
- Who it may be relevant to
- Registry conditions: Vitiligo Vulgaris, Psoriasis, Alopecia Areata, Atopic Dermatitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of the Effectiveness of the PALLAS Laser in the Treatment of Skin Diseases That Respond Well to UV Light
Overview
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
Interventions
- 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
Primary outcome measures
- Primary Endpoint: visible improvement of the treated skin disease. [Time frame: maximum 3 months]
Secondary outcome measures (1)
- Dermatology Life Quality Index (DLQI) [Time frame: Maximum 3 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patient under 18 years of age,
- pregnancy
- epilepsy,
- fever, infectious diseases,
- the patient is within one month or currently enrolled in another clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and — Szeged
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. PMID 12472364
- 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. PMID 9388408
- 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. PMID 11422057
Identifiers
NCT: NCT07250997 · MD-PALL-01 · CIV-HU-25-08-053914