Peterio™ - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments.
试验速览
- 阶段
- 不适用
- 发起方
- Scilex Ltd.
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
研究概览
简要总结
The purpose of this study is to determine whether a new laser system provides better safety and efficacy in hair removal than existing lasers.
详细描述
Lasers are a well-established, popular modality for removal of unwanted hair. The existing lasers are based on a wavelength that is specifically absorbed by the pigment melanin found in the hair follicle, where the energy is converted to heat resulting in a thermal injury.
However, lasers for hair removal are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. The purpose of the study is an evaluation safety and efficacy of a new laser based device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years old
- •Fitzpatrick skin types I to VI
排除标准
- •Age below 18 or above 75 year old
- •Use of photosensitive medications
- •Photosensitive diseases
- •Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
- •Exposure to sun or artificial tanning during the last 3-4 weeks
结局指标
主要结局
Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
Long term clearance will be calculated as the ratio between the value of the baseline hair count taken immediately before the first treatment, and the value obtained at the 3-6 month post treatment hair count.
次要结局
- Measuring treatment discomfort as graded by the patients.