A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Recovery ration
研究概览
简要总结
The researchers investigate the effect of a treatment with selective photothermolysis using a 595 nm pulsed dye laser on the blood vessel density and the nerve fibre density of a psoriatic lesion. By comparing tissue samples collected before and after two treatments, the researchers determine the relative effect of laser therapy on the (hyper)innervation of psoriatic skin.
详细描述
Vascular laser therapy for psoriasis seems to achieve a remarkably long treatment-free duration of remission. But why would sub-second heating of the blood vessels of the skin result in a year-long resolution of an infamously stubborn condition?
Unraveling the mechanism of action of laser therapy would not only allow for the improvement of existing laser therapy protocols but also, could open the door to a whole new range of interventions offering quasi-permanent solutions for patients. There is a high need for such enduring therapies: Psoriasis is both, a common and a costly skin condition. It affects between 1% and 9% of the population and has a very severe impact on the quality of life of the patient. It's chronic character implies lifelong treatment, and the associated risks and effort
This project aims to assess the effect of laser therapy on the blood vessels and (peripheral) innervation of psoriasis plaques. The primary objective is to quantify the regression and recovery of nerves compared to blood vessels. The researchers hypothesize that the recovery of nerves after Selective Photo Thermolysis (SPT) is decreased compared to the recovery of blood vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
tissue samples are described using random pre-assigned codes.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 69 years of age
- •Psoriasis vulgaris
- •Skin type I - III
- •Minimal surface of lesion of 3 cm2
- •Contralateral psoriasis vulgaris lesions located on chest, back, or upper legs
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study if:
- •The participant uses other treatments (than laser therapy) during the study or two weeks before the start of the study that are known to affect psoriasis
- •The participant suffers from any known neurological, vascular, or immunological condition other than psoriasis.
- •The participant is allergic to lidocaine
结局指标
主要结局
Recovery ration
时间窗: 6 months.
Relative change in the ratio of the linear nerve density and linear blood vessel density.
次要结局
- Recovery ratio vs lymphocyte infiltration(6 months)
- Clinical improvement(6 months)
研究者
Nick van der Beek
Managing director
ZBC MultiCare