Abstract：
BACKGROUND: Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HAVOL (Restylane® Volyme) is a flexible HA filler suited to contouring and volumizing the midface.
METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face.
RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events.
CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.
METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face.
RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events.
CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.
摘要：
背景：透明质酸（HA）填充剂治疗是手术的微创替代方法，可使脸颊丰满。HAVOL（Restylane®Volyme）是一种柔性HA填料，适用于使中表面轮廓化和体积化。
方法：这是随机的，评估者致盲，无治疗对照研究评估了HAVOL在中国受试者中用于矫正中方体积不足和中方轮廓缺陷的有效性和安全性。总共111名受试者随机接受HAVOL,37名受试者不接受治疗(对照)。主要终点是反应，在盲评估者评估的Medicis中面体积量表（MMVS）上，治疗组最后一次注射后6个月和对照组随机化后6个月，其中反应定义为面部两侧均较基线改善≥1点。
结果：在6个月时，HAVOL优于未治疗，达到主要目标：76%对8%的MMVS响应者，差异为68%(CI：55.7%-79.4%，p<0.0001)。在最后一次注射后12个月，这些效果持续了51％。大多数（≥96％）在第1个月时改善了面部中部丰满的美学外观（使用全球美学改善量表[GAIS]），在12个月内保持≥80%的效果。1个月后，3D摄影拍摄的体积变化增加至3.6mL（接近3.4mL的总注射体积），并在12个月内保持稳定。超过97％的人报告对HAVOL治疗后的结果满意。此外,HAVOL耐受性良好，无意外相关不良事件。
结论：这项研究表明，在中国人群中，HAVOL治疗有效且耐受性良好。
方法：这是随机的，评估者致盲，无治疗对照研究评估了HAVOL在中国受试者中用于矫正中方体积不足和中方轮廓缺陷的有效性和安全性。总共111名受试者随机接受HAVOL,37名受试者不接受治疗(对照)。主要终点是反应，在盲评估者评估的Medicis中面体积量表（MMVS）上，治疗组最后一次注射后6个月和对照组随机化后6个月，其中反应定义为面部两侧均较基线改善≥1点。
结果：在6个月时，HAVOL优于未治疗，达到主要目标：76%对8%的MMVS响应者，差异为68%(CI：55.7%-79.4%，p<0.0001)。在最后一次注射后12个月，这些效果持续了51％。大多数（≥96％）在第1个月时改善了面部中部丰满的美学外观（使用全球美学改善量表[GAIS]），在12个月内保持≥80%的效果。1个月后，3D摄影拍摄的体积变化增加至3.6mL（接近3.4mL的总注射体积），并在12个月内保持稳定。超过97％的人报告对HAVOL治疗后的结果满意。此外,HAVOL耐受性良好，无意外相关不良事件。
结论：这项研究表明，在中国人群中，HAVOL治疗有效且耐受性良好。
