NCT01331408已完成4 期
An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 61
- 试验地点
- 8
- 主要终点
- Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 20 years old
- •willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
- •understand and comply with the requirements of the study
- •be willing to understand and comply with the requirements of the study
- •be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
- •be a male or non-pregnant, non breast-feeding female.
- •give written informed consent to participate in the study
排除标准
- •Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
- •scar tissue in the area to be treated
- •subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
- •subjects with human immunodeficiency virus (HIV) associated lipodystrophy
- •subjects having undergone liposuction within 6 months prior to inclusion
- •BMI <20 or expected instable weight
- •insufficient tissue cover in the area to be treated
- •excessive skin laxity in the area to be treated
- •other injectable implant or permanent implant near or in the area to be treated
- •previous radiation therapy of tumors near or in the area to be treated
- •concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding disorders.
- •a presence or history of connective tissue diseases
- •ongoing immunosuppressive therapy
- •known allergies or hypersensitivity reactions towards anesthetics
- •previous inflammatory or hypersensitivity reactions towards products containing Hyaluronic acid
- •any condition which in the opinion of the investigator makes the subject unsuitable for inclusion use of any investigational drugs or devices within 30 days prior to inclusion.
结局指标
主要结局
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
时间窗: 6 Months
To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
次要结局
- Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12(12 Months)
- Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1(1 Month)
研究者
研究点 (8)
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