Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The changes in skin elasticity.
研究概览
简要总结
The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are:
- Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity
- The changes in texture and pore volume using Antera
- The changes in bioengineering assessment: melanin index, erythema index, sebum level
- Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.
详细描述
The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI < 25 kg/m2, and have mild to moderate facial laxity.
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
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-55 years
- •BMI < 25 kg/m2
- •Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)
排除标准
- •Pregnant or lactation
- •Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
- •Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion
- •Active skin infections
- •History of hypertrophic scars or keloids
结局指标
主要结局
The changes in skin elasticity.
时间窗: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in skin elasticity (R0, R2, R5) using Cutometer (%)
The changes in wrinkle.
时间窗: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in indentation of wrinkle using Antera (mm3)
The changes in nasolabial fold.
时间窗: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in nasolabial fold using Quantificare (mm3)
The changes in skin laxity.
时间窗: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in skin laxity using Quantificare (mm3)
次要结局
- The changes in pore volume.(4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.)
- Adverse events(4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.)
- The changes in skin texture.(4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.)
- The change in melanin index and erythema index.(4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.)
- The change in sebum level.(4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.)
研究者
Woraphong Manuskiatti, M.D.
Prof. Dr.
Mahidol University