NCT06243315Enrolling By Invitation不适用
A Prospective, Multicenter, Post-marketing Clinical Follow-up Research to Evaluate the Long-term Safety of Ellansé-S Dermal Filler Made of PCL Microspheres for the Correction of Moderate-to-severe Nasolabial Folds
AQTIS Medical B.V.1 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2023年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- MAEs
研究概览
简要总结
This research is intended to evaluate the long-term safety of Ellansé-S PCL dermal filler for the correction of moderate-to-severe NLFs.
374 subjects. This clinical trial is designed as a prospective, multicenter, post-marketing clinical follow-up trial to evaluate the long-term safety of the investigational product, dermal filler made of PCL microspheres, for the correction of moderate-to-severe NLFs
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old and above;
- •Subjects with moderate-to-severe nasolabial folds (3-4 level of WSRS scores) on both sides of the face
- •Intended to be treated with PCL microsphere filler;
- •Voluntarily participate in this test, cooperate with follow-up, and sign an informed consent form
排除标准
- •Obvious acne scar, pigmentation, active infection, inflammation, tumor, precancerous lesion or unhealed wound in the intended injection area;
- •Patients who have used permanent fillers (PMMA, hydrogel polymer, liquid silicone for injection, polyvinyl alcohol (PVA), bone cement, autologous fat, etc.) for nasolabial groove injection;
- •Patients who have received semi-permanent fillers (polycaprolactone, L-polylactic acid, hydroxyapatite, platelet-rich plasma, etc.) injection treatment in nasolabial sulch area in the past 24 months;
- •Patients who have received temporary fillers (hyaluronic acid, collagen, etc.) injection treatment in nasolabial groove in the past 12 months;
- •Patients who have received botox injection treatment in nasolabial sulci in the past 6 months;
- •The nasolabial groove has been treated with beauty plastic, focused ultrasound, chemical stripping, photoelectric (laser, photon, radio frequency) in the past 3 months;
- •Use of hormones or immunosuppressants within the past 1 month;
- •Subjects who have used anticoagulants in the last 2 weeks;
- •Subjects with a history of crabfoot, hyperplastic scars or cicatricial constitution;
- •Subjects with active sepsis;
- •Subjects with coagulation dysfunction;
- •Subjects with autoimmune diseases;
- •Allergic to polycaprolactone or known product ingredients;
- •Pregnant, pregnant and lactating subjects;
- •Participated in other clinical trials in the past 30 days;
- •Other situations determined by the researcher to be unsuitable for participation in this study;
结局指标
主要结局
MAEs
时间窗: 1 month,6 months,1 year, 2 years,3years,4years,5years
The incidence of MAEs associated with the investigational product will be collected for all visits
次要结局
- AE/SAE(1 month,6 months,1 year, 2 years,3years,4years,5years)
- GAIS scores after injection treatment(1 month,6 months,1 year, 2 years)
- Improvement of WSRS scores(1 month,6 months,1 year, 2 years)
研究者
研究点 (1)
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