NCT02751034已完成3 期
A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold
Medy-Tox4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds
详细描述
This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.
Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged between 30 and 70 years, inclusive
- •Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
- •Subjects with visually symmetrical bilateral nasolabial folds
- •Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
- •Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
- •Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form
排除标准
- •Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
- •Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
- •Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
- •Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
- •Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
- •Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
- •Subjects with a history of a hypertrophic scar or keloid
- •Subjects with a skin disease or wound infection at the investigational medical device injection site
- •Subjects who participated in another clinical trial within 30 days prior to screening
- •Pregnant or breastfeeding women or women of childbearing potential who are not using medically acceptable contraception or not consenting to practice birth control from screening to the end of trial
- •Subjects who are otherwise determined by the investigator as ineligible for this study
结局指标
主要结局
Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
时间窗: from baseline to 24 weeks
次要结局
- Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs(from baseline to 8, 16 weeks)
- Change on Wrinkle Severity Rating Scale as evaluated by an investigator(from baseline to 8, 16, 24 weeks)
- Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator(from baseline to 8, 16, 24 weeks)
- Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters(from baseline to 8, 16, 24 weeks)
- Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject(8, 16, 24 weeks after the injection)
- Visual Analogue Scale as evaluated by a subject(at 15, 30, 45, 60 minutes after the injection)
- Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator(8, 16, 24 weeks after the injection)
- Vital signs, physical examination, laboratory tests and adverse events(from baseline to 24 weeks)
研究者
研究点 (4)
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