A Prospective, Single-Arm, Interventional, Multicenter, Post-Market Clinical Follow-up (PMCF) Investigation to Evaluate the Performance and Safety of Injectable Poly-LLactic Acid Dermal Filler for the Treatment of Nasolabial Fold Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
研究概览
简要总结
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.
The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.
Participants will:
Receive 3 rounds of treatment and will be followed up for a total of 2 years.
详细描述
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.
The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.
Participants will:
Receive 3 rounds of treatment and will be followed up for a total of 2 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form
- •Male or female, ≥18 years old.
- •Immune-competent individuals.
- •Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.
排除标准
- •Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
- •Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
- •Pigmentation in NLF or having a history of hypo melanosis.
- •Susceptibility to keloid formation or hypertrophic scarring.
- •History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
- •History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.
- •Hemorrhagic disease or receiving anti-coagulant therapy.
- •Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.
- •Having received in the past 2 months immunosuppressant or systemic steroid therapy.
- •Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition.
- •Female who is pregnant and/or lactating
- •Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate
研究组 & 干预措施
Juläine
干预措施: Juläine (Device)
结局指标
主要结局
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
时间窗: 12 months after final injection
Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score. Score 1-5, Higher scores are a worse outcome.
次要结局
- Change in WSRS score(Up to 24 months after final injection)
- Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.(Up to 24 months after final injection)
- Change in Global Aesthetic in Improvement Scale(Up to 24 months after final injection)
- Percentage of subjects with improvement of at least 1 grade on the WSRS.(Up to 24 months after final injection)
- Change Face-Q score of Nasolabial Fold(Up to 24 months after final injection)
- Subject Satisfaction Scores(Up to 24 months after final injection)
- Mean WSRS of <2 at each follow-up time(Up to 24 months after final injection)