A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI)
研究概览
简要总结
This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-70 years.
- •Score of 3 to 4 on the WSRS (1 = absent, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) for both nasolabial folds.
- •Able and willing to provide written informed consent.
- •Willing to refrain from facial cosmetic procedures during the study.
排除标准
- •Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or 2 weeks after treatment.
- •History or current bleeding disorders.
- •Participation in another clinical trial within 1 month before screening.
- •Pregnant or breastfeeding women, or planning pregnancy.
- •Women of childbearing potential not using effective contraception.
研究组 & 干预措施
DMFI150
Single injection of DMFI150
干预措施: DMFI150 (Device)
结局指标
主要结局
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI)
时间窗: Baseline to Month 12
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. The EI will assess the change from baseline to Month 12.
次要结局
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI)(Baseline to Month 1,3,6,9,12)
- Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and by the Subject(Baseline to Month 1,3,6,9,12)
- Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)(Baseline through Month 12)