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首页> 外文期刊>Journal of cosmetic dermatology >Efficacy and safety of a new hyaluronic acid filler for nasolabial folds: A 52-week, multicenter, randomized, evaluator/subject-blind, split-face study
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Efficacy and safety of a new hyaluronic acid filler for nasolabial folds: A 52-week, multicenter, randomized, evaluator/subject-blind, split-face study

机译：新透明质酸填料对鼻折叠的功效和安全性：52周，多中心，随机，评估员/受试者盲，分裂研究

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Background Hyaluronic acid fillers are known to be effective for correction of nasolabial folds. Recently, a novel biphasic hyaluronic acid filler incorporating lidocaine, DIVAVIVA medium has been introduced. Objectives We compared the efficacy and safety between DIVAVIVA medium and Restylane Perlane Lidocaine for moderate to severe nasolabial folds. Methods This was a multicenter, randomized, evaluator/subject-blind, active-controlled, split-face study. A study 1 evaluated the efficacy and safety until 24 weeks. Extension study, study 2, included subjects who wanted to enroll and evaluated the efficacy and safety until 52 weeks. The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated. All adverse events were monitored. Results The mean change of WSRS at week 24 was -0.61 +/- 0.54 in DIVAVIVA medium group and -0.59 +/- 0.49 in Restylane Perlane Lidocaine group. The difference between two groups was 0.08, which was lower than noninferior limit. In study 2, the mean change of WSRS score at week 52 from baseline was -0.01 +/- 0.62 in DIVAVIVA group, 0.06 +/- 0.57 in Restylane Perlane Lidocaine group. The primary and secondary efficacy outcomes were also achieved in study 1 and 2. There was no significant difference in the incidence of adverse events between the two groups. Conclusion DIVAVIVA medium has comparable efficacy and safety with Restylane Perlane Lidocaine for correction of moderate to severe nasolabial folds.
机译：背景众所周知，透明质酸填充物对矫正鼻唇沟是有效的。最近，一种新型的含有利多卡因的双相透明质酸填充剂DIVAVIVA培养基被引入。目的：我们比较了DIVAVIVA medium和Restylane Perlane利多卡因治疗中重度鼻唇沟皱襞的有效性和安全性。方法这是一项多中心、随机、评估者/受试者盲、主动对照、裂面研究。研究1评估了24周前的疗效和安全性。扩展研究，即研究2，包括希望登记并评估疗效和安全性直到52周的受试者。对皱纹严重程度评定量表（WSRS）评分、全球审美改善量表和视觉模拟疼痛量表进行评估。对所有不良事件进行了监测。结果第24周时，DIVAVIVA培养基组WSRS的平均变化为-0.61+/-0.54，Restylane-Perlane利多卡因组WSRS的平均变化为-0.59+/-0.49。两组之间的差异为0.08，低于非劣效极限。在研究2中，第52周时，迪瓦维娃组WSRS评分与基线检查时相比的平均变化为-0.01+/-0.62，雷斯泰兰-帕兰利多卡因组WSRS评分的平均变化为0.06+/-0.57。研究1和2也取得了主要和次要疗效结果。两组之间的不良事件发生率没有显著差异。结论DIVAVIVA medium与Restylane Perlane利多卡因治疗中重度鼻唇沟皱襞的疗效和安全性相当。

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