Volume Restoration of the Aging Midface With Sculptra Aesthetic
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
研究概览
简要总结
The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic rejuvenation of the midface complex. The investigators plan to both qualitatively determine the restoration of midface architecture as well as quantitatively document the change in midface volume by employing three-dimensional (3D) surface imaging which critically analyzes volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic injections will experience significant improvement in facial midface volume restoration.
- Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
- Determine the mean change from baseline in facial contour via quantitative volumetric measurements
- Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
- Correlate the mean volumetric change in midfacial treatment area with the amount of product used
- Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
- Collect safety data
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-60 years old
- •BMI greater than 18.5 and less than 24.9
排除标准
- •Age less than 40 years or greater than 60 years
- •Prior surgical or non-surgical treatment to the midface within the past 2 years
- •Interested in seeking other treatments to the midface during the study period
- •Pregnant, lactating, or breast feeding
- •Hypersensitivity to poly-L-lactic acid, carboxymethylcellulose, or mannitol
- •Allergy to lidocaine or epinephrine
- •History of atopy, anaphylaxis, or multiple severe allergies
- •Current immunotherapy or history of autoimmune disease
- •History of or active stroke or myocardial infarction
- •History of or active connective tissue disease
- •History of or active bleeding disorders
- •History of or active cancer
- •Serious abnormalities in laboratory findings
- •Active hepatitis
- •Active infection or inflammatory process of skin
- •History of or risk factors for hypertrophic scarring or keloid formation
研究组 & 干预措施
Sculptra Aesthetic
Patients receiving Sculptra Aesthetic
干预措施: injectable poly-L-lactic acid (Drug)
结局指标
主要结局
Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
时间窗: 6 mo, 9 mo, 12 mo, 15 mo
次要结局
- Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system(12 mo)
- Correlate the mean volumetric change in midfacial volume with the amount of product used(12 mo)
- Time course and duration of volumetric correction from Sculptra Aesthetic treatment(15 mo)
研究者
Edwin F. Williams, III, M.D.
Principal Investigator
Williams Center Plastic Surgery Specialists