NCT00293163已完成4 期
A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.
Genzyme, a Sanofi Company6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- no difference in keloid and scar formation
研究概览
简要总结
To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale
排除标准
- •pregnant/lactating women
- •patients who previously received permanent facial implants or using over-the-counter products
结局指标
主要结局
no difference in keloid and scar formation
pigmentation disorders
hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique
次要结局
未报告次要终点
研究者
研究点 (6)
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