Gauglitz Gerd, Steckmeier Stephanie, Pötschke Julian, Schwaiger Hannah
Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.
Department of Plastic and Hand Surgery, Klinikum St Georg gGmbH, Leipzig, Germany.
Clin Cosmet Investig Dermatol. 2017 Dec 14;10:507-513. doi: 10.2147/CCID.S141906. eCollection 2017.
Cohesive Polydensified Matrix hyaluronic acid (CPM-HA) volumizer has been used successfully for several years to reverse biometric volume loss during facial aging. This observational study explored the additive effect on nasolabial folds when CPM-HA volumizer is injected into the neighboring cheek area.
In this open-label, prospective, postmarketing noninterventional study, 18 adult patients seeking esthetic enhancement of the lateral cheek hollows and cheekbone area were injected with CPM-HA volumizer integrated with lidocaine (CPM-HA-VL) in the upper or lower cheek area. Safety and performance of CPM-HA-VL up to 12 months after injection with follow-up visits at week 4 and month 3, 6, and 12 were assessed. The primary endpoint was improvement of cheek fullness on the validated Merz Aesthetics Scales. Additionally, changes in nasolabial folds were quantified using a phaseshift rapid in vivo measurement of skin optical three-dimensional (3D) in vivo measurement device.
Patients (94.4% female, median age 52 years, age range 39-69 years) were injected with a mean volume of 2.5±1.1 mL CPM-HA-VL per side. Immediately after injection, mean severity for upper and lower cheek fullness assessed on the validated MAS improved from 2.5±0.6 and 2.8±0.5, respectively, to 1.0±0.0, and remained unchanged through month 12. Improvement in relation to baseline was attested on the Global Aesthetics Improvement Scale for all assessments. Compared with baseline, the following assessments offered a statistical significance in the reduction of wrinkle depth of nasolabial folds (maximum depth reduction by 30.4% at 3 months) according to optical 3D in vivo measurements. Pain during injection was minimal and abated within 30 minutes. Treatment was well tolerated and led to great patient satisfaction.
CPM-HA-VL injected into the upper and lower cheeks led to long-lasting satisfactory cosmetic results in cheek augmentation as well as in reducing depth of nasolabial folds adjacent to the injection site.
凝聚性多密度基质透明质酸（CPM-HA）填充剂已成功应用数年，用于逆转面部衰老过程中的生物计量体积损失。本观察性研究探讨了将CPM-HA填充剂注射到邻近脸颊区域时对鼻唇沟的附加效果。
在这项开放标签、前瞻性、上市后非干预性研究中，18名寻求改善外侧脸颊凹陷和颧骨区域美观的成年患者在上脸颊或下脸颊区域注射了与利多卡因混合的CPM-HA填充剂（CPM-HA-VL）。在注射后4周、3个月、6个月和12个月进行随访，评估CPM-HA-VL在12个月内的安全性和性能。主要终点是在经过验证的默茨美学量表上脸颊丰满度的改善。此外，使用相移快速体内皮肤光学三维（3D）测量装置对鼻唇沟的变化进行量化。
患者（94.4%为女性，中位年龄52岁，年龄范围39 - 69岁）每侧平均注射2.5±1.1 mL CPM-HA-VL。注射后即刻，在经过验证的MAS上评估的上脸颊和下脸颊丰满度的平均严重程度分别从2.5±0.6和2.8±0.5改善至1.0±0.0，并在12个月内保持不变。在所有评估中，全球美学改善量表均证明相对于基线有所改善。根据光学3D体内测量，与基线相比，以下评估在减少鼻唇沟皱纹深度方面具有统计学意义（3个月时最大深度减少30.4%）。注射期间疼痛轻微，30分钟内缓解。治疗耐受性良好，患者满意度高。
在上脸颊和下脸颊注射CPM-HA-VL在脸颊填充以及减少注射部位附近鼻唇沟深度方面均产生了持久且令人满意的美容效果。
