聚左旋乳酸注射植入物 Sculptra 在改善面颊皱纹中的有效性和安全性。

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles.

出版信息

J Drugs Dermatol. 2024 Jan 1;23(1):1297-1305. doi: 10.36849/JDD.7729.

PMID:38206151

Abstract

BACKGROUND

The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control.

METHODS

Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12.

RESULTS

GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections.

CONCLUSION

Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments.

CLINICALTRIALS

gov registry number: NCT04124692J Drugs Dermatol. 2024;23(1):1297-1305. doi:10.36849/JDD.7729.

摘要

背景

本研究评估了 Sculptra 聚左旋乳酸（PLLA-SCA）注射治疗与非治疗对照相比，纠正脸颊皱纹的有效性和安全性。

方法

年龄>21 岁的有中度/重度脸颊皱纹的男性/女性免疫功能正常成年人（根据 Galderma 脸颊皱纹量表[GCWS]在休息时分级）按 2:1 随机分为 PLLA-SCA 注射（150mg；8mL 无菌注射用水复溶）+1mL 盐酸利多卡因（2%）组，立即在复溶后给药，或不治疗（对照组）。允许每月进行最多 3 次额外治疗，随访时间为第 7、9 和 12 个月。主要终点是第 12 个月时双侧脸颊 GCWS 在休息时至少改善 1 级。

结果

与对照组相比，PLLA-SCA 治疗在第 7、9 和 12 个月时的 GCWS 应答率明显更高（休息时 66.2%比 38.6%；P=0.0043）、70.6%比 31.1%；P<0.0001）和 71.6%比 26.1%；P<0.0001）。治疗研究者报告说皮肤光泽度改善（>95%）、紧致度改善（>88%）和下颌线轮廓改善（>85%）。PLLA-SCA 受者报告说，皮肤光泽度（>90%）、下垂（>84%）和紧致度（>91%）的改善以及自然外观（>85%）和重复治疗的愿望（>84%）的满意度水平很高。与 PLLA-SCA 注射相关的治疗相关不良事件大多为轻度，无与 PLLA-SCA 注射相关的严重事件。