A Prospective, Participant- and Evaluator-blinded, Randomized, Controlled, Split-face Clinical Investigation to Evaluate the Performance and Safety of Polycaprolactone 300 (DMFI300) 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 Evaluating Investigator (EI)
研究概览
简要总结
This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 Wrinkle Severity Rating Scale (WSRS) for both nasolabial folds.
- •Willing and able to provide written informed consent.
- •Willing to comply with study procedures and follow-up visits.
- •Willing to refrain from other facial cosmetic procedures affecting the nasolabial folds during the study.
排除标准
- •Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or planned use within 2 weeks after treatment.
- •History or presence of bleeding disorders.
- •Participation in another clinical investigation within 1 month prior to screening.
- •Pregnant or breastfeeding women, or women planning pregnancy during the study.
- •Women of childbearing potential not using an effective method of contraception.
研究组 & 干预措施
DMFI300
Injection of DMFI300
干预措施: DMFI300 (Device)
Ellansé-M
Injection of Ellansé-M
干预措施: Ellansé-M (Device)
结局指标
主要结局
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating 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 blinded EI will assess the change from baseline to Month 12 for each nasolabial fold treated with DMFI300 or Ellansé-M.
次要结局
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating Investigator (EI) and the Treating Investigator (TI)(Baseline to Month 1,3,6,9)
- Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject(Month 1,3,6,9,12)
- Subject Satisfaction With Treatment Using a Five-Point Likert Scale(Month 12)
- Proportion of Subjects Receiving Touch-up Treatment(Month 1)
- Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)(Baseline through Month 12)