NCT05685667已完成不适用
Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Skin hydration using a Corneometer® CM 825
研究概览
简要总结
The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.
详细描述
A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of needless laser injector versus needle injection for anti-aging effect of dermal filler.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who wanted to improve facial skin aging
排除标准
- •a history of skin rejuvenation treatment (including filler, botulinum toxin, lasers, chemical peeling, and topical retinoid) within 6 month prior to the start of the study
- •having a plan for skin rejuvenation treatment during the study
- •current pregnancy or breastfeeding
- •an allergy to polylactic acid (PLA) or hyaluronic acid (HA)
- •uncontrolled medical diseases
研究组 & 干预措施
Laser-induced microjet injector (Mirajet)
Experimental
The left/right assignment was sealed in a nontransparent envelop.
干预措施: needless laser injector (Mirajet) (Device)
Needle injection (control)
Active Comparator
The left/right assignment was sealed in a nontransparent envelop.
干预措施: needle injection (Device)
结局指标
主要结局
Skin hydration using a Corneometer® CM 825
时间窗: at 12 weeks after treatment
次要结局
- Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)(at 12 weeks after treatment)
- Skin elasticity using a Cutometer® MPA 580(at 12 weeks after treatment)
- Skin aging analyzed by three-dimensional photogrammetry(at 12 weeks after treatment)
- Patient's satisfaction score for antiaging effects(at 12 weeks after treatment)
- Adverse events related to the procedure(up to 24 weeks)
- Patient's pain score during treatment(up to 24 weeks)
研究者
Jung-Won Shin
Associate Professor
Seoul National University Bundang Hospital
研究点 (1)
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