Private clinic, Thionville, France.
Private clinic, Paris, France.
J Cosmet Dermatol. 2023 Feb;22(2):464-472. doi: 10.1111/jocd.15169. Epub 2022 Jul 31.
Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers.
To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines.
This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS).
In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up.
The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.
面部软组织的衰老变化导致了诸如唇萎缩、木偶纹和鼻唇沟加深等面部衰老的临床征象。这些变化可以通过真皮填充剂来改善。
评估一种含有 Tri-Hyal 技术的交联透明质酸基填充剂在治疗嘴唇、鼻唇沟和木偶纹方面的疗效、持久性和安全性。
这项前瞻性、多中心试验评估了三种不同区域（嘴唇、单独的鼻唇沟或伴有木偶纹皱纹）注射含有 25mg/ml 交联透明质酸和 0.3%利多卡因的软组织填充剂的效果。主要终点是一次注射后 3 周无需补针即可达到美学矫正。随访时间为 18 个月。使用整体美学评分（GAS）、基于照片量表的临床评分、高频超声成像和整体美学改善评分（GAIS）进行评估。
共对 100 名受试者进行了注射。所有治疗指征的 GAS 在 3 周时均显著改善（p<0.0001）。鼻唇沟的成功率最高（98.4%），其次是木偶纹（94.4%）和嘴唇（73.5%）。注射后 18 个月，分别有 91%、88%和 33%的受试者在鼻唇沟、木偶纹和嘴唇处仍保持成功。GAIS 对鼻唇沟的评分最高（SGAIS：71%；IGAIS：40%），其次是木偶纹（SGAIS：56%；IGAIS：33%）和嘴唇（SGAIS：30%；IGAIS：22%）。
该填充剂在所有适应证中均表现出高效性和安全性。在持久性方面存在区域性差异。因此，在注射前应与患者讨论区域性补针的必要性。
