A Prospective, Randomized, Comparative Study of a 1064-nm Fractional Picosecond Laser Versus Intense Pulsed Light in Facial Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Blinded GSP (Global Score for Photoaging) assessment by two dermatologists
研究概览
简要总结
This is a single-center, prospective, randomized controlled trial conducted at Huashan Hospital, Fudan University. The purpose of this study is to compare the effectiveness and safety of two non-invasive treatment options-1064-nm fractional picosecond laser and intense pulsed light (IPL)-for facial rejuvenation. A total of 38 participants seeking cosmetic improvement were randomly assigned to receive three sessions of either picosecond laser or IPL treatment at 4-6 week intervals.
Each participant was monitored throughout the treatment period and at one month after the final session. The study assessed improvements in skin texture, pigmentation, and wrinkles, as well as treatment-related side effects. All participants provided informed consent and received standardized post-treatment care instructions, including moisturization and sun protection. The results of this study may help guide non-surgical treatment options for skin aging.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •（1）Individuals aged 30-60 years with a GSP score of 1-4;（2）Fitzpatrick skin phototypes III-IV;（3）Written informed consent obtained.
排除标准
- •（1）Pregnant or lactating women;（2）Patients with severe systemic diseases;（3）Individuals with coagulation dysfunction;（4）Patients with mental disorders;（5）Photosensitive individuals;（6）Individuals with infections at the treatment site;（7）Individuals who have used photosensitive drugs within 4 weeks;（8）Individuals who have received other cosmetic treatments such as laser, intense pulsed light (IPL), radiofrequency, chemical peels (e.g., glycolic acid), fillers, etc., within 6 months;（9）Individuals with a personal or family history of keloids;（10）Individuals with a personal or family history of cutaneous squamous cell carcinoma or melanoma;（11）Individuals with a personal or family history of vitiligo;（12）Individuals with a history of intense sun exposure or ultraviolet (UV) radiation within 1 month.
研究组 & 干预措施
Picosecond Laser Group
干预措施: 1064-nm Fractional Picosecond Laser (PicoWay) (Device)
Intense Pulsed Light (IPL) Group
干预措施: Intense Pulsed Light Therapy (M22 IPL System) (Device)
结局指标
主要结局
Blinded GSP (Global Score for Photoaging) assessment by two dermatologists
时间窗: 1 month after third treatment (approximately 12-16 weeks after baseline)
Global skin photoaging score assessed by blinded dermatologists using the Global Skin Photoaging (GSP) Scale. Scale range: 0-4, where higher scores indicate more severe photoaging.
次要结局
- Blinded GSP scoring(baseline (before first treatment), before second treatment (approximately 4-6 weeks after baseline), before third treatment (approximately 8-12 weeks after baseline))
- Quantitative Skin Pigmentation and Erythema Assessment Using SkinColorCatch(baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks))
- Transepidermal Water Loss (TEWL) Measurement Using Delfin Vapometer(baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks))
- Standardized VISIA Photographic Documentation(baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks))
- Incidence of Adverse Events(before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks))
- Regional Fine Line and Dyschromia Grading by Dermatologists(before second treatment (approximately 4-6 weeks after baseline), before third treatment (approximately 8-12 weeks after baseline), and 1 month after third treatment (approximately 12-16 weeks after baseline))
- Quantitative Assessment of Skin Roughness Using C-Cube Imaging System(baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks))
研究者
Yanjun Dan
Resident Physician
Huashan Hospital