Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-HU-25-08-053914 | Other Identifier | National Centre for Public Health and Pharmacy, Budapest |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pallas Laser treated | Other | UVB treated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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/ | maximum 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Maximum 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Score | At the last visit, the patient assesses the improvement: Patient satisfaction scale: 0 = extremely dissatisfied
| maximum 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lajos Kemény, professor, MD, DSc, MHAS | Contact | +36305152884 | kemeny.lajos@med.u-szeged.hu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology | Recruiting | Szeged | Csongrád-Csanád Vármegye | 6720 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12472364 | Background | 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. | |
| 9388408 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| D011565 | Psoriasis |
| D000506 | Alopecia Areata |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 11422057 | Background | 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. |
| D017444 | Skin Diseases, Papulosquamous |
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |