NCT00360932已完成不适用
An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- To evaluate, by Fitzpatrick skin type and by gender, long-term safety of Poly-L-Lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy.
研究概览
简要总结
5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate, by Fitzpatrick skin type and by gender, long-term safety of Poly-L-Lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy.
时间窗: 5 years
次要结局
- Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.(5 years)
- Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;(5 years)
- Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and(5 years)
研究者
研究点 (1)
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