NCT Number: NCT07250997
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Szeged, Csongrád-Csanád Vármegye, 6720, Hungary
Location status: Recruiting
Lajos Kemény, professor, MD, DSc, MHAS
CONTACT
Lajos Kemény, professor, MD, DSc, MHAS
PRINCIPAL_INVESTIGATOR
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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/
Time frame: Maximum 3 months
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.
Time frame: maximum 3 months
At the last visit, the patient assesses the improvement:
Patient satisfaction scale:
0 = extremely dissatisfied
Contact information is provided by the study sponsor or research team.
Szeged University
Other
Study of the Effectiveness of the PALLAS Laser in the Treatment of Skin Diseases That Respond Well to UV Light
Acronym: PALLAS-UV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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