A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 867
- 试验地点
- 19
- 主要终点
- Percentage of Participants With Any Adverse Events of Interest (AEIs)
研究概览
简要总结
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects seeking correction of shallow to deep NLF contour deficiencies.
排除标准
- •Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
- •Subjects that are less than 18 or greater than 75 years of age.
结局指标
主要结局
Percentage of Participants With Any Adverse Events of Interest (AEIs)
时间窗: Up to 5 years
AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported.
Percentage of Participants With Any Injection Site Nodule and/or Papule
时间窗: Up to 5 years
Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to \[\>=\] 0.5 (cm); papule less than \[\<\] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported.
次要结局
- Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5(Baseline, Months 6,13 and Years 2,3 4,5)
- Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale(At 6,13 months, 2, 3, 4 and 5 years)
- Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5(Baseline, Months 6,13 and Years 2,3 4,5)
- Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5(Baseline, Months 6,13 and Years 2,3 4,5)
- Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale(At 6,13 months, 2, 3, 4 and 5 years)
- Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5(Baseline, Months 6,13 and Years 2,3 4,5)