Real-World Evidence on the Routine Use, Efficacy, and Safety of a Hyaluronic Acid-Based Dermal Filler in the Periorbital Region.

IF 2 3区医学 Q2 SURGERY

Aesthetic Plastic Surgery Pub Date : 2025-05-29 DOI:10.1007/s00266-025-04809-9

Tahera Bhojani-Lynch, Sabrina Shah-Desai, Jean-Christophe Bichet, Bárbara Magalhães, Kevin Poupard

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引用次数: 0

Abstract

Background: The appearance of the periorbital region is essential in facial aesthetic perception and is a frequent concern of patients seeking rejuvenation. TEOSYAL® PureSense Redensity 2 (R2) has a 10-year track record of effectively and safely treating the under-eye area, specifically the tear trough.

Methods: A prospective, observational study aimed to investigate the efficacy and safety of R2 in a real-world setting for aesthetic indications. Participants received at least one treatment injection with R2, and investigators followed their routine injection techniques and indications. The primary endpoint was the Global Aesthetic Improvement Scale (GAIS) score recorded 3 months post-injection. Secondary efficacy outcomes included subject and investigator satisfaction, as well as GAIS scores at later timepoints. Safety was monitored by documenting common treatment responses (CTRs) and adverse events (AEs).

Results: The 136 subjects enrolled in EYELIGHT received 958 initial injections, of which 451 (47.1%) were performed with R2: 89 (35.3%) tear trough, 61 (24.2%) palpebromalar groove, 45 (17.9%) outer canthus, 38 (15.1%) crow's feet, and 19 (7.5%) brow. A GAIS improvement of more than 70% was achieved for the tear trough and remaining periorbital indications, with most subjects reporting satisfaction with treatment (84.3%). Treatment effect was observed up to 12 months post-injection. All CTRs were mild or moderate and resolved within a month. No severe AEs were reported.

Conclusion: Real-world evidence confirmed the 10-year long success of R2 as an effective and safe treatment of the tear trough. Based on this evidence, its use extends beyond the tear trough, showing effectiveness and safety in the whole periorbital area.

Level of evidence iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

查看原文本刊更多论文

基于透明质酸的真皮填充物在眶周区域的常规使用、有效性和安全性的真实世界证据。

背景：眶周区域的外观在面部美感中是必不可少的，也是寻求返老还童的患者经常关注的问题。TEOSYAL®PureSense Redensity 2 （R2）具有10年有效和安全治疗眼下区域的记录，特别是泪液槽。方法：一项前瞻性观察性研究，旨在探讨R2在现实世界中用于美学适应症的疗效和安全性。参与者至少接受一次R2治疗注射，研究者遵循他们的常规注射技术和适应症。主要终点是注射后3个月的GAIS评分。次要疗效结果包括受试者和研究者满意度，以及稍后时间点的GAIS评分。通过记录常见治疗反应（CTRs）和不良事件（ae）来监测安全性。结果：136例受试者接受了958次初始注射，其中451例（47.1%）进行了R2：泪沟89例（35.3%），上睑颧沟61例（24.2%），外眼角45例（17.9%），鱼尾纹38例（15.1%），眉部19例（7.5%）。泪槽和其余眶周指征的GAIS改善超过70%，大多数受试者报告对治疗满意（84.3%）。注射后12个月观察治疗效果。所有CTRs均为轻度或中度，并在一个月内消退。无严重不良反应报告。结论：现实世界的证据证实了R2作为泪槽有效和安全的治疗方法长达10年的成功。基于这一证据，它的使用范围超出了撕裂槽，在整个眶周区域显示出有效性和安全性。证据等级iii：本刊要求作者为每篇文章指定证据等级。有关这些循证医学评级的完整描述，请参阅目录或在线作者说明www.springer.com/00266。

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来源期刊

Aesthetic Plastic Surgery 医学-外科

CiteScore

4.40

自引率

25.00%

发文量

479

审稿时长

3 months

期刊介绍： Aesthetic Plastic Surgery is a publication of the International Society of Aesthetic Plastic Surgery and the official journal of the European Association of Societies of Aesthetic Plastic Surgery (EASAPS), Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica (SICPRE), Vereinigung der Deutschen Aesthetisch Plastischen Chirurgen (VDAPC), the Romanian Aesthetic Surgery Society (RASS), Asociación Española de Cirugía Estética Plástica (AECEP), La Sociedad Argentina de Cirugía Plástica, Estética y Reparadora (SACPER), the Rhinoplasty Society of Europe (RSE), the Iranian Society of Plastic and Aesthetic Surgeons (ISPAS), the Singapore Association of Plastic Surgeons (SAPS), the Australasian Society of Aesthetic Plastic Surgeons (ASAPS), the Egyptian Society of Plastic and Reconstructive Surgeons (ESPRS), and the Sociedad Chilena de Cirugía Plástica, Reconstructiva y Estética (SCCP). Aesthetic Plastic Surgery provides a forum for original articles advancing the art of aesthetic plastic surgery. Many describe surgical craftsmanship; others deal with complications in surgical procedures and methods by which to treat or avoid them. Coverage includes "second thoughts" on established techniques, which might be abandoned, modified, or improved. Also included are case histories; improvements in surgical instruments, pharmaceuticals, and operating room equipment; and discussions of problems such as the role of psychosocial factors in the doctor-patient and the patient-public interrelationships. Aesthetic Plastic Surgery is covered in Current Contents/Clinical Medicine, SciSearch, Research Alert, Index Medicus-Medline, and Excerpta Medica/Embase.