Midface Projection Using Biostimulatory Poly-l-Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial.

IF 2.5 3区医学 Q2 DERMATOLOGY Dermatologic Surgery Pub Date : 2024-10-17 DOI:10.1097/DSS.0000000000004434

Sabrina G Fabi, Jennifer Htd Le, Inna Prygova, Daniel Bråsäter

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Abstract

Background: Correction of cheek wrinkles using poly-l-lactic acid (PLLA-SCA) was demonstrated in a 12-month study.

Objective: This analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data.

Methods: Subjects received PLLA-SCA (reconstituted in 8 mL of sterile water + 1 mL of 2% lidocaine) in both cheeks or no treatment (control). Assessments included the Galderma Cheek Wrinkle Scale (GCWS), aesthetic improvement, and 3D photography. In subjects with severe GCWS at baseline, Canfield software analyzed 3D images for change from baseline in midface volume projection and volume change of both cheeks at Month 9.

Results: The primary study showed a statistically significant higher at-rest GCWS responder rate at Month 12 for PLLA-SCA, 71.6%, versus control, 26.1% (p < .0001). In this Month 9 analysis, mean midface volume projection demonstrated a positive volume shift for PLLA-SCA (left: 0.45 mm; right: 0.34 mm; n = 46) versus control (left: 0.25 mm; right: -0.01 mm; n = 21). Midface volume and max projection changes for PLLA-SCA were +4.88 mL/+1.62 mm (left), +2.84 mL/+1.12 mm (right) versus +0.26 mL/+0.34 mm (left), +0.68 mL/+0.37 mm (right) for control.

Conclusion: Poly-l-lactic acid-treatment of subjects with severe GCWS had a clinically meaningful lifting effect in both cheeks (positive volume shift, positive volume change, and max projection) in the midface.

Clinical trial registry number: NCT04124692.

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使用生物刺激性聚乳酸注射植入物进行面中部投影：面颊皱纹试验的分组分析。

背景：一项为期 12 个月的研究显示，使用聚乳酸（PLLA-SCA）可矫正脸颊皱纹：一项为期12个月的研究显示，使用聚乳酸（PLLA-SCA）可矫正面颊皱纹：本分析使用三维照相机评估PLLA-SCA的提升效果与基线相比的变化，以提供更多量化数据：受试者双颊接受 PLLA-SCA（用 8 mL 无菌水+1 mL 2% 利多卡因重组）或不接受治疗（对照组）。评估包括Galderma面颊皱纹量表（GCWS）、美学改善和3D摄影。对于基线值为严重 GCWS 的受试者，Canfield 软件会分析三维图像，以确定与基线值相比，受试者在第 9 个月时的中面部容积投影和双颊容积变化：主要研究结果显示，在第 12 个月时，PLLA-SCA 的静息 GCWS 回复率为 71.6%，而对照组为 26.1%，差异有统计学意义（P < .0001）。在第 9 个月的分析中，PLLA-SCA（左：0.45 毫米；右：0.34 毫米；n = 46）与对照组（左：0.25 毫米；右：-0.01 毫米；n = 21）相比，平均中面部体积投影显示出正的体积移动。PLLA-SCA的中面体积和最大投影变化分别为+4.88 mL/+1.62 mm（左）、+2.84 mL/+1.12 mm（右），而对照组为+0.26 mL/+0.34 mm（左）、+0.68 mL/+0.37 mm（右）：临床试验登记号：NCT04124692：临床试验登记号：NCT04124692。

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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来源期刊

Dermatologic Surgery 医学-皮肤病学

CiteScore

3.10

自引率

16.70%

发文量

547

期刊介绍： Exclusively devoted to dermatologic surgery, the Dermatologic Surgery journal publishes the most clinically comprehensive and up-to-date information in its field. This unique monthly journal provides today’s most expansive and in-depth coverage of cosmetic and reconstructive skin surgery and skin cancer through peer-reviewed original articles, extensive illustrations, case reports, ongoing features, literature reviews and correspondence. The journal provides information on the latest scientific information for all types of dermatologic surgery including: -Ambulatory phlebectomy- Blepharoplasty- Body contouring- Chemical peels- Cryosurgery- Curettage and desiccation- Dermabrasion- Excision and closure- Flap Surgery- Grafting- Hair restoration surgery- Injectable neuromodulators- Laser surgery- Liposuction- Microdermabrasion- Microlipoinjection- Micropigmentation- Mohs micrographic surgery- Nail surgery- Phlebology- Sclerotherapy- Skin cancer surgery- Skin resurfacing- Soft-tissue fillers. Dermatologists, dermatologic surgeons, plastic surgeons, oculoplastic surgeons and facial plastic surgeons consider this a must-read publication for anyone in the field.