Kerscher Martina, Agsten Karla, Kravtsov Maria, Prager Welf
Department of Cosmetic Science, University of Hamburg.
SCIderm GmbH, Hamburg, Germany.
Clin Cosmet Investig Dermatol. 2017 Jun 29;10:239-247. doi: 10.2147/CCID.S135441. eCollection 2017.
Enhancement of the midface can be achieved with volumizing hyaluronic acid (HA) fillers.
The objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix 26 mg/mL HA gel (CPM-26) and Vycross 20 mg/ml HA gel (VYC-20) in a controlled, randomized, evaluator-blind, split-face clinical study.
Subjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS) received CPM-26 on one side and VYC-20 on the contralateral side of the face. Effectiveness assessments were performed by blinded evaluators including photographic and live MAS ratings and live Global Aesthetic Improvement Scale (GAIS) ratings. Calculations of anatomical volume variations at month 3 (M3), month 6 (M6), month 12 (M12) and month 18 (M18) were also performed.
Non-inferiority of CPM-26 versus VYC-20 was demonstrated at M3 (primary end point) based on MAS. GAIS rating showed that significantly more subjects had better improvement with CPM-26 than with VYC-20 at month 1, M3, M12 and M18 (=0.0032, =0.0074, =0.0384 and =0.0110, respectively). Standardized evaluation of volume variations from baseline to M3, M12 and M18 showed that CPM-26 created more volume augmentation at all time points, and the difference was significant at M3.
CPM-26 was non-inferior to VYC-20 based on MAS ratings at M3 and demonstrated a favorable safety and effectiveness profile for midfacial volume enhancement with results lasting up to M18.
使用含透明质酸（HA）的填充剂增加容量可实现中面部的改善。
本研究的目的是在一项对照、随机、评估者盲法、半脸临床研究中比较26mg/mL凝聚性多密度基质HA凝胶（CPM-26）和20mg/mL交联透明质酸凝胶（VYC-20）的安全性和有效性。
在美思美学量表（MAS）上有中度至重度颧部容量缺失的受试者，一侧面部接受CPM-26，对侧面部接受VYC-20。由盲法评估者进行有效性评估，包括照片和现场MAS评分以及现场全球美学改善量表（GAIS）评分。还进行了第3个月（M3）、第6个月（M6）、第12个月（M12）和第18个月（M18）时解剖学容量变化的计算。
基于MAS，在M3（主要终点）时证明CPM-26不劣于VYC-20。GAIS评分显示，在第1个月、M3、M12和M18时，使用CPM-26的受试者改善情况明显优于使用VYC-20的受试者（分别为=0.0032、=0.0074、=0.0384和=0.0110）。从基线到M3、M12和M18的容量变化标准化评估显示，CPM-26在所有时间点都产生了更多的容量增加，且在M3时差异显著。
基于M3时的MAS评分，CPM-26不劣于VYC-20，并且在中面部容量增加方面显示出良好的安全性和有效性，效果可持续至M18。
