NCT01918839已完成不适用
Clinical Study to Evaluate the Efficacy and Safety of Injection With VINCI Plus as Compared to Restylane-L in Correction of Nasolabial Fold
D.med2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Wrinkle Severity Rating Scale (WSRS) Evaluation
研究概览
简要总结
This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between the ages of 30-65, at the point of screening, wrinkles on both sides of treatment area (nasolabial fold) are in the 3rd or 4th level on the WSRS(Wrinkle Severity Rating Score)
- •Surrounding soft tissue of wrinkles on both sides of nose and lips are sagging
- •Wrinkles of both sides of nose and lips are visually symmetric
- •Agrees to stop all other treatment of facial wrinkle improvement including dermatology treatment during clinical trial
- •Able to understand and follow instructions and participate the entire period of the clinical trial
- •Subject voluntarily agrees to participate in clinical trial and gives informed written consent
排除标准
- •At the point of screening, intradermal test results show skin irritation to medical devices of clinical trial
- •Within 2 weeks before the date of screening, subject has taken antithrombotic (with the exception of low dose aspirin 100mg, up to 300mg/day) or non-steroidal anti-inflammatory medication
- •Case where subject has abnormal liver function or blood coagulation, has to take antithrombotic medication (with the exception of low dose aspirin 100mg, up to 300mg/day) during clinical trial
- •Subject has used facial topical liniment (steroids, retinoids: excluding only medicines and cosmetics) within 4 weeks before date of screening or plans to continue using facial topical liniment during clinical trial
- •Within 6 months before date of screening, subject has received anti-wrinkle or acne treatment
- •Within 6 months before date of screening, subject has received facial microdermabrasion treatment, skin regeneration/rejuvenation treatment, plastic surgery, or cosmetic surgery (including Botox injections)
- •Within 1 year before date of screening, subject has received CaHA (Calcium Hydroxyapatite) treatment on clinical trial medical device treatment area
- •Subject has cured facial gel (Softform) or silicone implants inserted as permanent facial expansion
- •Within 1 year before, subject had an illness that caused scarring or has scars on clinical trial medical device treatment area
- •Subject has facial skin disease or skin wound infection that affects the clinical trial
- •Weak immune system or suspect that the immune system is weak
- •History of anaphylaxis or severe allergic complexity
- •History of hypertrophic scar or keloid
- •In the past, if there were adverse effects from EMLA Cream (if EMLA Cream was not used, the exclusion criteria for subjects applicable)
- •History of hypersensitivity to Lidocaine
- •Cardiovascular, digestive, respiratory, endocrine, central nervous system disorders that seems clinically significant or had a mental illness that had a significant impact on a previous clinical trial or currently has a mental illness
- •Within 30 days before screening, subject participated in other clinical trials
- •Female subjects of childbearing potential does not agree to a medically accepted method of contraception for the period of the clinical trial Medically acceptable methods of contraception: condoms; oral contraception continued for at least three months; or if intrauterine is used, installed a contraceptive device
- •Pregnant women or nursing mothers
- •In addition to the above, the test director or person in charge medically judges there are clinically significant findings that are improper for the clinical trial
结局指标
主要结局
Wrinkle Severity Rating Scale (WSRS) Evaluation
时间窗: At 12 weeks
Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks
次要结局
- Wrinkle Severity Rating Scale (WSRS) Evaluation(At 2 weeks, 6 weeks)
- Global Aesthetic Improvement Scale (GAIS) Evaluation(At 2 weeks, 6 weeks and 12 weeks)
- VAS pain assessment at each time point(at injection and 15, 30, 45, and 60 min after injection)
研究者
研究点 (2)
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