J Drugs Dermatol. 2022 May 1;21(5):481-487. doi: 10.36849/JDD.6737.
Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks.
A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting.
Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity.
CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.
使用羟基磷灰石钙（CaHA）进行软组织填充是一种通用技术，可用于填充线条、紧致皮肤、提升、塑形和增加体积。本研究旨在通过利多卡因（CaHA（+））对鼻唇沟（NLFs）、木偶纹线和/或脸颊进行整体治疗，确认该产品的安全性和有效性。
在这项开放性研究中，共有 207 名中重度面部容量不足的患者接受了 CaHA（+）治疗。有效性评估包括 Merz 美学量表（MAS）、研究者和患者评估的整体美学改善量表（iGAIS/sGAIS）和 FACE-QTM 问卷。根据盲法评分，应答率定义为 MAS 至少改善一个点。通过不良事件报告评估安全性。
主要终点在末次注射后 12 周评估。NLFs、木偶纹线和脸颊的应答率分别为 93.6%、88.7%和 81.9%，均显著高于预定义的 60%阈值（P<0.0001）。研究者和患者评估的 GAIS 是一致的，并在整个研究过程中显示出高改善率，在 iGAIS 上第 4 周时达到峰值，为 98.0%，在末次注射后 12 周时达到 93.5%。在 18 个月后，大多数患者（52.5%）仍通过 sGAIS 感知到改善。此外，总 FACE-Q 评分显示患者对治疗非常满意。所有相关的治疗出现的不良反应均为短暂的，且预期的注射部位反应大多为轻度至中度。
CaHA（+）在真实环境中治疗 NLFs、木偶纹线和脸颊容量缺失方面已被证实具有安全性和有效性，可长达 18 个月。J 皮肤病药物学杂志。2022;21(5):481-487. doi:10.36849/JDD.6737.
