Alopecia Areata, Atopic Dermatitis, Psoriasis, Vitiligo Vulgaris
Conditions
Keywords
UVB laser treatment, PALLAS laser, vitiligo, psoriasis, alopecia areata, atopic dermatitis
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
Interventions
DEVICEUVB 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.
Sponsors
Szeged University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: visible improvement of the treated skin disease. | 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/ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) | 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. |
Countries
Hungary
Contacts
CONTACTLajos Kemény, professor, MD, DSc, MHAS
Outcome results
None listed