NCT00869687已完成不适用
A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.
研究概览
简要总结
The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.
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
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If female, the subject must use appropriate form of birth control.
排除标准
- •History of allergies or an allergic reaction to local numbing medications (e.g., lidocaine, etc.), latex, or silicone.
- •History of forming large scars following an accident or surgery.
- •History of any bleeding problems.
- •Redness, swelling, or signs of infection behind the right or left ear between the area of the earlobe and hairline.
- •Pimples, rashes, scarring or any other skin changes behind the right or left ear between the area of the earlobe and hairline.
- •History of any medical problems (for example, heart attack, stroke, diabetes/high blood sugar, hepatitis, human immunodeficiency virus (HIV), severe asthma, rheumatoid arthritis, emphysema, breathing problems). Subjects with high blood pressure or high cholesterol may qualify for the study if there have been no changes in their medications for three (3) months.
- •History of cancer within five (5) years.
- •Previous cosmetic surgery or cosmetic procedures affecting the area behind the ear.
- •Subject who plans to have any facial or ear surgery within the next year.
- •History of alcohol or drug abuse.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.
时间窗: 6 months
次要结局
- Change from baseline in level of Type 1 collagen at 3 months and 12 months(3 and 12 months)
- Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist.(3, 6, and 12 months)
- Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory.(3, 6, and 12 months)
- Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months.(3, 6, and 12 months)
- Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist.(3, 6, and 12 months)
研究者
研究点 (1)
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