David Michel, Braccini Frederic, Garcia Philippe, Loreto Frederic, Benadiba Laurent, Gorj Mihai, Grand-Vincent Anne, Rumyantseva Mathey Elena, Deutsch Jean-Jacques, Ehlinger Agnès, Cartier Hugues, Nadra Karim, Fanian Ferial
Private Clinic, Metz, France.
Private Clinic, Nice, France.
Clin Cosmet Investig Dermatol. 2023 Jul 13;16:1795-1805. doi: 10.2147/CCID.S395353. eCollection 2023.
Injectable hyaluronic acid-based fillers are commonly used for the correction of skin contour irregularities and to smooth skin depressions formed by volume loss during the aging process. These fillers are particularly efficient to restore perioral skin depressions/wrinkles or to correct topographical anomalies. The European directives require a continuous evaluation of the performance of these medical devices, particularly for CE marked products.
An 18-month prospective randomized single-blind study for the efficacy and safety of ART FILLER Universal (AFU) was performed on the lips, the nasolabial folds, and the marionettes lines. The evaluations were performed on 153 subjects enrolled in this study. The efficacy, the longevity, and the safety were evaluated for the injected areas via area specific clinical scoring after a single injection with the filler and with no re-touch.
We showed here that filler injection induced potent improvements of volume restoration after a single injection on all the treated areas. These beneficial properties of the filler were significant 3 weeks after injection and during the whole study period. Moreover, injections of the filler were well tolerated by the subjects. The recorded adverse events are routinely seen with HA fillers for face volume corrections, and most of these local reactions resolved within 14 days.
AFU was well tolerated and showed a continuous efficacy for at least 18 months, in exploratory analyses.
可注射的透明质酸基填充剂常用于矫正皮肤轮廓不规则，并抚平衰老过程中因容量流失而形成的皮肤凹陷。这些填充剂在修复口周皮肤凹陷/皱纹或矫正地形异常方面特别有效。欧洲指令要求对这些医疗器械的性能进行持续评估，特别是对于带有CE标志的产品。
对153名受试者的嘴唇、鼻唇沟和木偶纹进行了一项为期18个月的前瞻性随机单盲研究，以评估ART FILLER Universal（AFU）的疗效和安全性。在单次注射填充剂且不再进行补打后，通过特定区域的临床评分对注射区域的疗效、持久性和安全性进行评估。
我们在此表明，在所有治疗区域单次注射填充剂后，可显著改善容量恢复。填充剂的这些有益特性在注射后3周及整个研究期间都很显著。此外，受试者对填充剂注射的耐受性良好。记录到的不良事件在使用透明质酸填充剂进行面部容量矫正时很常见，且大多数局部反应在14天内消退。
在探索性分析中，AFU耐受性良好，且至少18个月内持续有效。
