Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- TGS change
研究概览
简要总结
The goal is to compare a novel yellow laser, based on semiconductor technology, with traditional green laser, in the treatment of cheek telangiectasias. The trial design is randomized split-face double-blinded study with 20-30 volunteers. The improvement will be assessed using a 7-point Telangiectasia Grading Scale.
详细描述
Trial design: The study is a comparative randomized split-face double-blinded study without a control group. It enables a comparison between two lasers; namely the KTP laser and the investigational PHOTOLASE laser. The split-face design eliminates the individual biases and the randomization eliminates the possible small variations in the symmetry of the telangiectasias on the face. The double-blinded assessment eliminates the physicians' and the subjects' subjective and objective bias.
Methods: The subjects will be treated with a 532-nm green KTP laser and a 585-nm yellow PHOTOLASE laser; different laser on each side of a face. A total of one or two treatments will be given based on the response of the first treatment. The improvement of subjects' telangiectasia will be graded after the final treatment according to a 7-point Telangiectasia Grading Scale (TGS) by a blinded physician using images taken with Visia imaging system. The usability, reliability and treatment characteristics of PHOTOLASE laser will be qualitatively assessed by the treating physicians (not blinded).
Objectives: The primary objective is to assess how the PHOTOLASE laser compares to the KTP laser in the treatment of facial telangiectasia in terms of the treatment outcomes. The secondary objective is to assess the usability, reliability and treatment characteristics of the PHOTOLASE laser from the perspective of the user.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects are required to be Finnish speaking adults with symmetrical facial telangiectasia, volunteering to participate in the clinical trial.
- •The subjects have to have a Fitzpatrick skin phototype I-IV.
排除标准
- •pregnancy
- •lactation
- •hemophilic condition
- •Fitzpatrick skin phototype V-VI
- •drug or alcohol abuse
- •subjects who are under guardianship
- •subjects with significant tanning less than 6 weeks prior to the treatment day.
- •unbalanced basic diseases, such as diabetes, heart disease, cancer etc.
研究组 & 干预措施
Split-face group 1
In group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE.
干预措施: KTP (Device)
Split-face group 1
In group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE.
干预措施: PHOTOLASE (Device)
Split-face group 2
In group 2 the right side of the face will be treated with KTP and left side with PHOTOLASE.
干预措施: PHOTOLASE (Device)
Split-face group 2
In group 2 the right side of the face will be treated with KTP and left side with PHOTOLASE.
干预措施: KTP (Device)
结局指标
主要结局
TGS change
时间窗: Before treatment and 1-2 months after the intervention.
Telangiectasia grading scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is -1 to 5, where -1 means worsening of the condition, 0 means no change, 1 means 0-25% improvement, 2 means 25-50% improvement, 3 means 50-75% improvement, 4 means 75-100% improvement and 5 means total clearance.
次要结局
- Amount of treatment-related adverse effects using a 4-point scale.(Immediately after treatment and 2-3 days after treatment.)
- VAS pain measurement(Immediately after intervention.)