Prospective, Multicenter, Controlled, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of Diluted RADIESSE® for Treatment of Décolleté Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 18
- 主要终点
- Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24
研究概览
简要总结
Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between ≥ 30 and ≤ 65 years old at the time of the screening.
- •Subjects seeking improvement of décolleté wrinkles.
排除标准
- •Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.
- •Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté.
- •Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.
研究组 & 干预措施
Treatment with diluted Radiesse
Injection of Décolleté Wrinkles with diluted Radiesse
干预措施: Treatment with diluted Radiesse (Device)
Delayed treatment with diluted Radiesse
Delayed injection of Décolleté Wrinkles with diluted Radiesse
干预措施: Treatment with diluted Radiesse (Device)
结局指标
主要结局
Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24
时间窗: Week 24
The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.
次要结局
- Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24(Week 24)
- Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24(Week 24)
- Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24(Week 24)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse(From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84))