NCT06428214已完成不适用
A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface
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
- 45
- 试验地点
- 6
- 主要终点
- Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8
研究概览
简要总结
The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
- •Males or non-pregnant, non-breastfeeding females, over the age of
- •Intent to receive treatment for temporary augmentation in the chin region.
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
- •Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- •Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
- •Any previous aesthetic procedures or implants.
- •Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
- •Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
- •Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
结局指标
主要结局
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8
时间窗: At week 8
次要结局
- Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8(At weeks 4 and 8)
- Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8(At week 8)
- Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8(At week 8)
- Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4(At week 4)
- Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8(At week 8)
- Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8(At week 8)
研究者
研究点 (6)
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