Long-term Efficacy and Safety of a Hyaluronic Acid-Based Dermal Filler With Tri-Hyal Technology to Enhance Lip Volume.

Aesthetic surgery journal. Open forum Pub Date : 2025-01-28 eCollection Date: 2025-01-01 DOI:10.1093/asjof/ojae110
Philippe Kestemont, Ferial Fanian, Philippe Garcia, Anne Grand-Vincent, Laurent Benadiba, Henry Delmar, Isaac Bodokh, Patrick Brun, Frédéric Braccini, Christophe Desouches, Jérôme Paris, Ismahane Guimiot, Catherine Salomon, Patrick Trévidic
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Abstract

Background: Interventions to enhance lip volume and shape are common aesthetic procedures to counter signs of aging.

Objectives: This study aimed to assess the efficacy of Art Filler Lips (AFL), with or without retouching, at restoring lip shape and volume, tolerability, and persistence over 18 months.

Methods: During this open-label study, AFL (≤2.0 mL) was injected into the upper, lower, and/or both red lips and borders at baseline (D0). Patients were evaluated at D21, when, if necessary, retouching was performed. Patients were evaluated at D42, D90, D180, D270, D360, D450, and D540. The primary assessment was based on evaluation at D21 using the Medicis Lip Fullness Scale (MLFS). Satisfactory volume restoration was defined as an improvement of ≥1 point vs D0. Secondary outcomes were adverse events (AEs), and investigator and patient satisfaction rates based on Global Aesthetic Improvement Scores.

Results: Among 73 patients (97% females; 54.4 ± 10.5 years), 56% of lips were injected without any retouch. Mean MLFS scores either for upper and lower lips separately or together, significantly improved by D21 for the patients without retouching or D42 for those with (all P < .0001). At D21/42, 99% of upper lips, 94% of lower lips, and 96% of both lips showed satisfactory volume restoration. This proportion declined between D21/42 and D540. The most reported immediate AEs were swelling, sensitivity, and pain and were mild to moderate, lasting for <2 weeks.

Conclusions: AFL is well tolerated and produces a sustained objective and subjective lip volume restoration and shape.

Level of evidence 4 risk:

三透明质酸真皮填充剂增强唇部体积的长期疗效和安全性。
背景:增强嘴唇体积和形状的干预措施是对抗衰老迹象的常见美容程序。目的:本研究旨在评估艺术填充唇(AFL)在修复唇形和体积,耐受性和持续时间超过18个月的效果,有或没有修饰。方法:在这项开放标签研究中,在基线时将AFL(≤2.0 mL)注射到上、下和/或两侧红唇和边界(D0)。在D21时对患者进行评估,必要时进行修饰。对患者的D42、D90、D180、D270、D360、D450和D540进行评估。初步评估是基于使用美第奇唇部丰满度量表(MLFS)在D21的评估。满意的体积恢复定义为与D0相比改善≥1点。次要结局是不良事件(ae),以及基于全球美学改善评分的研究者和患者满意度。结果:73例患者中,97%为女性;54.4±10.5年),56%的唇部注射未做任何修饰。上下唇单独或一起的平均MLFS评分,未修饰的患者显著提高D21,修饰的患者显著提高D42(均P < 0.0001)。在D21/42时,99%的上唇、94%的下唇和96%的双唇体积恢复满意。这一比例在D21/42和D540之间有所下降。大多数报告的即时不良反应是肿胀、敏感和疼痛,并且是轻至中度的,持续的结论:AFL具有良好的耐受性,并产生持续的客观和主观唇体积和形状的恢复。证据4级风险:
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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