Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Patient Satisfaction With Validated FACE-Q Aesthetics Survey
研究概览
简要总结
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
详细描述
Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes.
This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients 40 - 65 years of age
排除标准
- •Male patients
- •Prior surgical facial rejuvenation procedures
- •Neck lift
- •Blepharoplasty
- •Facial fat grafting
- •Prior minimally invasive rejuvenation procedure ≤ 12 months
- •Known contraindications to devices or drugs used in this study
- •Facial paralysis
- •Congenital facial asymmetry
- •Pregnant women
- •Patient actively taking blood thinners
研究组 & 干预措施
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
Hyaluronic acid
干预措施: Restylane-L® (Drug)
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
Hyaluronic acid
干预措施: Restylane-L® Lyft (Drug)
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
Hyaluronic acid
干预措施: Restylane Silk® (Drug)
结局指标
主要结局
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
时间窗: 2 week post injections
Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain. The absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.
次要结局
- Correlate Patient Satisfaction With Volumetric Measurements(upto 90 days)
- Volumetric Changes of Treatment(immediately post injection, 2 weeks, 4 weeks, and 12 weeks)