Study of the Effectiveness of the PALLAS Laser in the Treatment of Skin Diseases That Respond Well to UV Light
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary Endpoint: visible improvement of the treated skin disease.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient under 18 years of age,
- •fever, infectious diseases,
- •the patient is within one month or currently enrolled in another clinical trial.
研究组 & 干预措施
Pallas Laser treated
UVB treated patients
干预措施: UVB laser treatment (Device)
结局指标
主要结局
Primary Endpoint: visible improvement of the treated skin disease.
时间窗: 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/
次要结局
- Dermatology Life Quality Index (DLQI)(Maximum 3 months)
研究者
Prof. Dr. Kemény Lajos
Professor, MD, DSc, MHAS
Szeged University