Multicenter, Prospective, Observational Study to Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S Applied to the Facial Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Nasolabial Folds
研究概览
简要总结
This study in multi-center, prospective and observational study. The purpose of this study is to observe effects and safety of hyaluronic acid filler series, eptq S and eptq Lidocaine S, for facial volume and folds.
详细描述
Participants for this study are treated with eptq S and eptq Lidocaine S for smoothing nasolabial folds or volumizing mid-face or lips. Treating period is around 24 weeks. Facial volume and wrinkle condition, participants' satisfaction, and safety would be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female adults aged 19 years and older.
- •Meet one of the following among individuals who want temporary improvement of facial wrinkles and volume.
- •Wrinkle Severity Rating Scale score 3 or 4 for Nasolabial fold.
- •Mid-Face Volume Deficit Scale score 3 or greater.
- •Medicis Lip Fullness Scale score 1-
- •In cases of 2-1) and 2-2), participants must meet both sides (right and left) to be eligible for enrollment.
- •For 3), the Medicis Lip Fullness Scale scores 1-2 at the target sites for procedures (upper lip, lower lip, up & down) eligible for enrollment
- •Voluntarily agree to participate in this observational study in written consent form.
排除标准
- •Received anti-thrombotics (except low-dose aspirin [100 mg, maximum 300 mg/day]) within 2 weeks from screening.
- •Currently have or have a history of bleeding disorder.
- •applied graft/prosthesis or biomaterials, including hyaluronic acid, polycaprolactone, collagen filler, lifting (threads, laser, etc.), and Botulinum toxin, at the site for indication within 24 weeks from screening.
- •Skin disorder or wound infection on the face that affects this study
- •Have history of side effects of EMLA cream or equivalent lidocaine agent.
- •History of hypersensitivity to hyaluronic acid agent(s).
- •Other contraindications as per the [Precautions for Use] in the approved label for the study device.
- •Determined as not eligible for the study by the investigator.
结局指标
主要结局
Nasolabial Folds
时间窗: 24 weeks
Percentage(%) of subjects whose Wrinkle Severity Rating Scale was improved during follow-up period compared to the baseline (1: No visible fold - 5: Extremly deep fold)
Mid-Face Volume
时间窗: 24 weeks
Percentage(%) of subjects whose Mid-face Volume Deficit Scale was improved during follow-up period compared to the base line (0: None - 5: Severe)
Lip Volume
时间窗: 12 weeks
Percentage(%) of subjects whose Medicis Lip Fullness Scale was improved during follow-up period compared to the baseline (1: Very thin - 5: Very full)
次要结局
- Improvement satisfaction assessment(24 weeks)