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Safety and Efficacy of Cross-linked Hyaluronic Acid Revanesse Ultra for Treatment of Nasolabial Folds
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摘要:
目的 评价水晶纳交联透明质酸应用于中国人群鼻唇沟皱纹治疗的安全性和有效性。 方法 本临床试验方案为前瞻性、随机、阳性对照的非劣效性试验。本中心共招募120例受试者, 根据入选标准和排除标准确定受试对象并自愿签署知情同意书。受试者按入组时间顺序编号并随机分为试验组和对照组, 分别采用水晶纳交联透明质酸和瑞蓝2对受试者双侧鼻唇沟纹进行填充治疗。每例患者注射次数为1~2次(第1次注射后4周, 可进行第2次修正注射), 注射量根据皱纹深度每侧不超过2 ml。所有受试者在最后一次注射后第1、3、6、12个月进行随访, 随访内容包括对受试者按统一标准拍照、受试者上交填写的注射后15 d局部不良反应日志、研究者和受试者分别进行皱纹严重程度评价(Wrinkle Severity Rating Scale, WSRS)。在试验结束后, 独立第三方作WSRS, 以6个月评价结果作为主要疗效指标, WSRS与基线比较改善1个或以上等级定义为有效。筛选时与6个月随访时进行血尿常规和肝肾功能等实验室检查。 结果 两组受试者各项基线指标差异均无统计学意义, 两组间均衡可比。独立第三方对两组受试者术后6个月随访WSRS结果显示两组差异无统计学意义(P > 0.05);术后6个月两组WSRS与基线比较鼻唇沟纹等级改善差异无统计学意义(P=0.105);术后6个月试验组和对照组有效率差异无统计学意义(93.0%比96.7%, P=0.431)。试验过程中出现2例不良反应, 但与产品和手术可能无关。无手术相关的实验室检查结果改变。 结论 水晶纳交联透明质酸用于鼻唇沟纹治疗试验期间未见与材料相关的不良反应, 其组织相容性好, 试验者能够接受。水晶纳交联透明质酸对鼻唇沟纹有明显改善作用, 且疗效非劣效于对照材料瑞蓝2。 Abstract:Objective To evaluate the safety and efficacy of cross-linked hyaluronic acid Revanesse Ultra for treatment of nasolabial folds in Chinese population. Methods A total of 120 participants were enrolled in this prospective, randomized, positive controlled, non-inferiority clinical trial in accordance to inclusion and exclusion criteria, and signed informed consents were obtained. The participants were numbered in the order of enrollment and randomized into Restylane group and Revanesse group, receiving hyaluronic acid injection to correct bilateral nasolabial folds. Each person received 1 or 2 times of injection (a touch-up injection could be administered 4 weeks post the first injection). According to the original depth of the wrinkles, no more than 2 ml hyaluronic acid was injected into each side. All the participants were followed up at 1, 3, 6, and 12 months after the last injection and standardized photographs were taken at each visit. All the participants were asked to fill the form of local adverse events within the first 15 days after injection. Investigators and the participants both evaluated wrinkles based on Wrinkle Severity Rating Scale (WSRS). The WSRS score according to the pictures of 6 months post-injection were compared with the pictures which were taken before the injection (baseline) by independent staff at the end of the trial. One or more grades of WSRS improvement compared with the baseline was considered as effective. Laboratory tests including blood and urine routine, liver and renal function tests were carried out at screening visit and 6 months after injection. Results The baseline features between the two groups were comparable (all P > 0.05). There was no significant difference in the WSRS 6 months after injection between the two groups (P > 0.05). There was no significant difference in the WSRS improvement compared with baseline between the two groups (P=0.105). There was no significant difference in the rate of effectiveness between the two groups (93.0% vs. 96.7%, P=0.431). Two participants reported minor adverse events, although both of which might not be associated with the product or procedure. No laboratory test change was found during the trial. Conclusions No severe adverse event associated with the injection material was observed during this clinical trial. According to the result, Revanesse Ultra may have good histocompatibility and tolerance. It could provide obvious improvement in the nasolabial folds, with effectiveness comparable to that of Restylane. -
Key words:
- hyaluronic acid /
- nasolabial folds /
- dermal filler /
- efficacy /
- safety
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表 1 受试者基线资料
组别 性别[例(%)] 年龄(x±s，岁) 左鼻唇沟纹基线等级[例(%)] 右鼻唇沟纹基线等级[例(%)] 男 女 3级 4级 3级 4级 对照组(n=60) 2(3.3) 58(96.7) 44.83±8.92 37(61.7) 23(38.3) 35(58.3) 25(41.7) 试验组(n=60) 1(1.7) 59(98.3) 45.31±8.62 34(56.7) 26(43.3) 32(53.3) 27(45.0) P值 1 0.762 0.577 0.713 
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表 2 注射后第6个月受试者鼻唇沟纹等级第三方评价结果[例(%)]
组别 左鼻唇沟纹等级 右鼻唇沟纹等级 1级 2级 3级 1级 2级 3级 对照组(n=60) 24(40.0) 27(45.0) 9(15.0) 26(43.3) 26(43.3) 8(13.3) 试验组(n=57) 25(43.9) 24(42.1) 8(14.0) 27(47.7) 26(45.6) 4(7.0) χ2值 0.179 1.301 P值 0.914 0.522
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表 3 注射后第6个月受试者鼻唇沟纹改善等级第三方评价结果[例(%)]
组别 无改善或更差 改善1个等级 改善2个等级 改善3个等级 改善4个等级[例(%)] 对照组(n=60) 2(3.3) 28(46.7) 23(38.3) 7(11.7) 0(0) 试验组(n=57) 4(7.0) 15(26.3) 32(56.1) 6(10.5) 0(0) P值 0.105
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表 4 鼻唇沟注射试验期间发生的不良事件/反应
组别 不良事件/反应名称 术后出现时间(d) 严重程度 与产品关系 与手术关系[例(%)] 结果评定 因不良事件退出 对照组 腰椎间盘突出 88 重 无关 无关 已缓解 否 对照组 双面鼻唇沟肿物 338 轻 可能无关 可能无关 仍存在 否 试验组 注射部位毛囊炎(多发) 289 中 可能无关 可能无关 已缓解 否 试验组 面颈部老化矫正术 143 轻 无关 无关 仍存在 是 试验组 子宫切除 26 中 无关 无关 已缓解 否
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[1] Hotta T. Dermal fillers. The next generation[J].Plast Surg Nurs, 2004, 24:14-19. doi: 10.1097/00006527-200401000-00006 [2] França Wanick FB, Almeida Issa MC, Luiz RR, et al. Skin remodeling using hyaluronic acid filler injections in photo-aged faces[J]. Dermatol Surg, 2016, 42:352-359. doi: 10.1097/DSS.0000000000000659 [3] Roh NK, Kim MJ, Lee YW, et al. A split-face study of the effects of a stabilized hyaluronic acid-based gel of nonanimal origin for facial skin rejuvenation using a stamp-type multineedle injector:a randomized clinical trial[J]. Plast Reconstr Surg, 2016, 137:809-816. doi: 10.1097/01.prs.0000480686.68275.60 -
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