Nikolis Andreas, Enright Kaitlyn M, Lazarova Desislava, Sampalis John
Université de Montreal and McGill University, Montreal, Quebec, Canada.
Erevna Innovations Inc, Clinical Research Unit, Westmount, Quebec, Canada.
Aesthet Surg J Open Forum. 2020 Feb 6;2(1):ojaa005. doi: 10.1093/asjof/ojaa005. eCollection 2020 Jan.
Aesthetic physicians have several hundred injectable products to select from. Due to differences in their manufacturing technology, these products display varying biophysical qualities, such as their cohesivity and lift capacity. Currently, there is no guidance to objectively selecting the best product for a particular patient. Therefore, an algorithmic approach is required to take specific skin characteristics into consideration.
To evaluate (1) whether subjects seeking injectable treatments for midfacial volume loss and/or contour deficiency can be stratified based on specific skin characteristics (eg, thickness, fat quantity, bony structure) and (2) whether particular hyaluronic acid fillers perform best when used in such particular strata.
This was a prospective, Phase IV, open-label, single-center clinical trial. Thirty female patients with midface/cheek volume loss and/or contour deficiency were recruited (mean age, 53.5 years; SD, 12.57; range, 35-75 years). Subjects were treated with either Restylane Lyft (HA) or Restylane Volyme (HA) and followed for 4 months post-injection. Treatment allocation was based on the treating physician's clinical evaluation and compared with ultrasound evaluation. Ultrasound images were used to confirm stratification. Safety and efficacy assessments were performed at each study visit: baseline, week 2, week 4, week 8, and week 16. Subgroup analyses evaluated whether particular strata performed best when treated with specific products.
The 2 investigative products varied in their efficacy, depending on the characteristics of the subject.
The use of a treatment algorithm may improve outcomes for patients seeking injectable treatments for midfacial volume loss and contour deficiencies.
美容医生有数百种可注射产品可供选择。由于其制造技术的差异，这些产品呈现出不同的生物物理特性，如内聚性和提升能力。目前，尚无客观选择适合特定患者的最佳产品的指导。因此，需要一种算法方法来考虑特定的皮肤特征。
评估（1）寻求治疗面部中部容积减少和/或轮廓缺陷的可注射治疗的受试者是否可以根据特定的皮肤特征（如厚度、脂肪量、骨骼结构）进行分层，以及（2）特定的透明质酸填充剂在这些特定分层中使用时是否效果最佳。
这是一项前瞻性、IV期、开放标签、单中心临床试验。招募了30名面部中部/脸颊容积减少和/或轮廓缺陷的女性患者（平均年龄53.5岁；标准差12.57；范围35 - 75岁）。受试者接受瑞蓝丽瑅（HA）或瑞蓝唯瑅（HA）治疗，并在注射后随访4个月。治疗分配基于主治医生的临床评估，并与超声评估进行比较。超声图像用于确认分层。在每次研究访视时进行安全性和有效性评估：基线、第2周、第4周、第8周和第16周。亚组分析评估特定分层在使用特定产品治疗时是否效果最佳。
两种研究产品的疗效因受试者特征而异。
使用治疗算法可能会改善寻求治疗面部中部容积减少和轮廓缺陷的可注射治疗的患者的治疗效果。
