A Randomized Controlled Trial of the Efficacy of a Non-ablative Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Visia CR imaging system
研究概览
简要总结
- Facial aging is a progressive, multifactor-induced and multidimensional process which is naturally irreversible. The prominent clinical features of skin aging include loss of volume, pigmentation irregularity, low light reflectance, static and dynamic wrinkles, etc.
- The development of superpulsed CO2 and Erbium: YAG 2940 nm resurfacing lasers was considered as the "gold standard" for the treatment of facial aging [8,9]. However, many drawbacks including intraoperative pain, post procedural erythema, edema, high risk of changes of pigmentation and long downtime have drawn concerns to patients and practitioners. Therefore, the facial rejuvenation therapies based on combined modalities to target various factors simutaneously have raised more and more interests.
- The Fotona 4D laser platform incorporates the long pulsed 1064 nm and 2940 nm lasers, which provides versatile modalities to target various skin aging problems simultaneously. The 1064 nm laser can penetrate deep into the skin to explode pigment particles, destroy blood vessels and heat the dermal collagen by targeting melanin and haemoglobin. The 2940 nm Er:YAG laser in Fotona 4D system integrates a non-ablative Smooth® mode and cold peel SupErficial™ mode. the half-face treated by a 2940 nm laser alone showed a significant improvement on indexes of skin wrinkles, texture, pores and elasticity as compared to the baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ranged in age from 35 to 60 years old.
- •Patients had Dover scale between 2-4
- •Fitzpatrick wrinkles scale between 1-3
- •medium to very severe nasolabial fold depression with morphological scores of 2 - 3 points.
排除标准
- •pregnancy,
- •liver or kidney functional abnormality,
- •skin ulceration
- •skin cancer
- •coagulation disorders
- •patients on drugs of photosensitizing or anticoagulation agents
- •systemic diseases such as cardiovascular disease, epilepsy, diabetes.
研究组 & 干预措施
2940 nm group
Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 2940 nm laser alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.
干预措施: Fotona 4D 2940 nm laser (Radiation)
1064 nm group
Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 1064 nm laser alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.
干预措施: Fotona 4D 1064 nm laser (Radiation)
Combined treatment group
Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 2940 nm or 1064 nm laser (Fotona, Slovenia, EU) alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.
干预措施: Fotona 4D 1064 nm laser (Radiation)
Combined treatment group
Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 2940 nm or 1064 nm laser (Fotona, Slovenia, EU) alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.
干预措施: Fotona 4D 2940 nm laser (Radiation)
结局指标
主要结局
Visia CR imaging system
时间窗: change from week0 to week24
With fast capture times and lighting modes designed to enhance the visualization of skin features, VISIA®-CR (Canfield Scientific, Inc. USA) is the standard in repeatable clinical imaging. Visia CR imaging system can be used to assess the skin wrinkles, and elasticity
次要结局
- Multiprobe skin testing system(change from week0 to week24)
研究者
xjpfW
Head of Dermatology
Xijing Hospital