NCT01529203已完成3 期
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subject Satisfaction for the Full Face
研究概览
简要总结
The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.
This will be an open, multi-centre study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria
排除标准
- •Female subject who is pregnant, nursing or planning a pregnancy during the study
- •Subject with any contraindications to the injection of hyaluronic acid (see package inserts)
- •Subject with any contraindications to the injection of botulinum toxin (see package insert)
- •Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin
- •Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments
- •Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations
- •Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit
研究组 & 干预措施
Azzalure and Restylane
Other
All subjects will be injected with Azzalure and Restylane
干预措施: Botulinum Toxin Type A (Azzalure) (Drug)
Azzalure and Restylane
Other
All subjects will be injected with Azzalure and Restylane
干预措施: Restylane ranges (Device)
结局指标
主要结局
Subject Satisfaction for the Full Face
时间窗: Month 6
based on the subject's satisfaction questionnaire
次要结局
- Global Aesthetic Improvement From Baseline(Week 3)
- Related Adverse Event(Month 6)
研究者
研究点 (1)
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