Hertz-Kleptow Dominique, Hanschmann Angelika, Hofmann Matthias, Reuther Tilmann, Kerscher Martina
University of Hamburg, Division of Biochemistry and Molecular Biology, Cosmetic Science, D-20146 Hamburg, Germany.
Global Clinical Development, Merz Pharmaceuticals GmbH, Frankfurt, Germany.
Clin Cosmet Investig Dermatol. 2019 Aug 13;12:563-572. doi: 10.2147/CCID.S209256. eCollection 2019.
Hyaluronic acid (HA) fillers are popular for the treatment of signs of facial skin aging.
The objective of this study was to confirm the performance and safety of a new cohesive polydensified matrix HA filler ([CPM-HA20G, Belotero Revive, lidocaine-free], Merz Pharmaceuticals GmbH, Frankfurt, Germany) for the treatment of early signs of facial skin aging by use of biophysical measurements as well as subject and investigator satisfaction.
Twenty-five healthy female subjects with signs of facial skin aging were enrolled in this open-label, rater-blinded, observational post-market clinical follow-up study, and received 20 micropuncture treatments of 50 µL CPM-HA20G each into the lower cheek area at three injection visits 4 weeks apart. Objective biophysical assessments were conducted to demonstrate effects on viscoelastic properties of the skin, surface roughness, tone and radiance, and hydration, at baseline and at all follow-up visits up to 36 weeks.
CPM-HA20G significantly increased gross elasticity of the skin (at weeks 9 and 12), skin firmness (up to week 24), skin tone and radiance and skin hydration (all up to 36 weeks). Significant reduction of skin fatigue (up to 9 weeks), skin roughness (up to 28 weeks), and redness (up to 36 weeks) was also observed. Subjects and blinded investigator were highly satisfied with the treatment outcomes. The treating investigator reported a high level of satisfaction with the ease of injection and the clinical performance of the device. Moreover, data demonstrated a good safety profile of the device.
CPM-HA20G is considered to be an effective and safe HA injectable for skin revitalization in patients suffering from signs of skin aging and loss of skin elasticity. It seems to be a perfect early intervention approach in patients that do not need volumizing treatment and a combination approach in older patients with more pronounced aging.
透明质酸（HA）填充剂在治疗面部皮肤衰老迹象方面很受欢迎。
本研究的目的是通过生物物理测量以及受试者和研究者的满意度，确认一种新型的凝聚性多密度基质HA填充剂（[CPM-HA20G，Belotero Revive，不含利多卡因]，德国美兹制药有限公司，法兰克福）治疗面部皮肤早期衰老迹象的性能和安全性。
25名有面部皮肤衰老迹象的健康女性受试者参加了这项开放标签、评分者盲法、上市后临床观察随访研究，在相隔4周的三次注射就诊时，每次在下脸颊区域接受20次50μL CPM-HA20G的微针注射治疗。在基线以及长达36周的所有随访就诊时，进行客观生物物理评估，以证明对皮肤粘弹性、表面粗糙度、肤色和光泽以及水合作用的影响。
CPM-HA20G显著提高了皮肤的总体弹性（在第9周和第12周）、皮肤紧致度（直至第24周）、肤色和光泽以及皮肤水合作用（均直至36周）。还观察到皮肤疲劳（直至9周）、皮肤粗糙度（直至28周）和发红（直至36周）显著降低。受试者和盲法研究者对治疗结果高度满意。治疗研究者报告对注射的 ease of injection（此处原文有误，推测为ease of use，即使用便利性）和器械的临床性能高度满意。此外，数据表明该器械具有良好的安全性。
CPM-HA20G被认为是一种有效且安全的HA可注射剂，可用于改善有皮肤衰老迹象和皮肤弹性丧失的患者的皮肤活力。对于不需要容积填充治疗的患者，它似乎是一种完美的早期干预方法，对于衰老更明显的老年患者则是一种联合治疗方法。
