NCT02565784已完成不适用
An Open, Evaluator-blinded, Non-comparative, Multi-center Study to Assess the Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects intent to undergo facial filler treatment for either volume loss or contouring
- •Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
- •Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
- •Facial appearance as Han Chinese
- •Non-pregnant, non-breast feeding female
- •Signed informed consent
排除标准
- •Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
- •History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
- •Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
- •Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
- •Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
- •Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
- •Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
- •Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
- •Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
结局指标
主要结局
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
时间窗: 6 Months
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
次要结局
- Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator(6 and 12 Months after first and second treatment, respectively)
- Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator(6 and 12 Months after first and second treatment, respectively)
研究者
研究点 (2)
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