Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
研究概览
简要总结
This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician
排除标准
- •Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
- •Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
- •Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
- •Subjects with a history of alcoholism or drug abuse or dependence
结局指标
主要结局
Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
时间窗: Baseline, Week 8
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4
时间窗: Baseline, Week 4
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8
时间窗: Baseline, Week 8
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
时间窗: Baseline, Week 8, Week 52
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8
时间窗: Baseline, Week 8
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
时间窗: Baseline, Week 8, Week 104
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
时间窗: Baseline, Week 8, Week 52
The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
时间窗: Baseline, Week 8, Week 78
The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4
时间窗: Baseline, Week 4
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4
时间窗: Baseline, Week 4
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
时间窗: Baseline, Week 8, Week 104
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
时间窗: Baseline, Week 8, Week 52
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
时间窗: Baseline, Week 8, Week 78
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
时间窗: Baseline, Week 8, Week 104
The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
时间窗: Baseline, Week 8, Week 78
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
次要结局
- Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)(Baseline, Weeks 4, 8, 52, 78 and 104)
- Subject's Assessment of Global Aesthetic Improvement Score (GAIS)(Baseline, Weeks 4, 8, 52, 78 and 104)
- Change From Baseline in the MFVDS Score(Baseline, Weeks 4, 8, 52, 78 and 104)
- Change From Baseline in the Subject's Self-Perception of Age (SPA)(Baseline, Weeks 4, 8, 52, 78 and 104)
- Physician Assessment of Global Aesthetic Improvement Score (GAIS)(Baseline, Weeks 4, 8, 52, 78 and 104)
- Percentage of Participants Satisfied or Very Satisfied With the Treatment(Week 8)