PALLAS Laser for Skin Diseases

ConditionsVitiligo Vulgaris Psoriasis Alopecia Areata Atopic Dermatitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorSzeged University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient under 18 years of age,

pregnancy

epilepsy,

fever, infectious diseases,

Trial design

Design model

Single group

Treatments tested in this trial

UVB laser treatment
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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Pallas Laser treatedOther 1 intervention

Trial outcomes

Primary outcomes

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/

Time frame

maximum 3 months

Secondary outcomes

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.

Time frame

Maximum 3 months

Other outcomes

Patient Satisfaction Score

At the last visit, the patient assesses the improvement: Patient satisfaction scale: 0 = extremely dissatisfied 1. = dissatisfied 2. = satisfied 3. = extremely satisfied

Time frame

maximum 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Szeged University

Lead sponsor

Source ClinicalTrials.gov

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