Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 4
- 主要终点
- ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.
详细描述
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
干预措施: Radiesse Injectable Dermal Filler (Device)
Delayed Treatment
Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
干预措施: Radiesse Injectable Dermal Filler (Device)
结局指标
主要结局
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
时间窗: 3 months from baseline
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
时间窗: 3 months from baseline
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
时间窗: 3 months from baseline
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
次要结局
- Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand(3, 6, 9, and 12 months from baseline)
- Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only(3 months from baseline)
- Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only(3 months from baseline)
- Difficulty Performing Activities During Prior Week, Both Hands(Baseline and 3, 6, 9, and 12 months post-treatment)
- Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand(3, 6, 9, and 12 months from baseline)
- Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments(3, 6, 9, and 12 months from baseline)
- Normal Work During Prior Week Evaluation(Baseline and 3, 6, 9, and 12 months post-treatment)
- ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject(3, 6, 9, and 12 months from baseline)
- Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study(3, 6, 9, and 12 months from baseline)
- Patient Satisfaction Evaluation(3, 6, 9, and 12 months from baseline)
- Mean Hand Function Rating During Prior Week(Baseline and 3, 6, 9, and 12 months post-treatment)
- ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand(3, 6, 9, and 12 months from baseline)
- Physician Satisfaction Evaluation(3, 6, 9, and 12 months from baseline)
- Difficulty Performing Activities During Prior Week(Baseline and 3, 6, 9, and 12 months post-treatment)