Abstract：
UNASSIGNED: To investigate the efficacy and safety of Cutegel® MAX (Cutegel) in the correction of moderate-to-severe nasolabial folds (NLFS) compared to Restylane® (Restylane, control).
UNASSIGNED: This study was a 52-week, multicenter, randomized, double-blinded, active-controlled clinical trial. Qualified participants with moderate-to-severe NLFs were randomly assigned in a 1:1 ratio to receive Cutegel or Restylane. For the primary efficacy endpoint, the response rate was defined as the percentage of subjects exhibiting an improvement of at least one-point based on blinded evaluation of Wrinkle Severity Rating Scale (WSRS) at 24 weeks after injection. Other secondary efficacy endpoints and treatment-emergent adverse events (TEAEs) were assessed.
UNASSIGNED: Of 340 subjects randomized, 317 completed the week 52 visit. In the per protocol set (PPS), the blinded evaluator-assessed response rates at week 24 were 81.17% for Cutegel versus 77.56% for Restylane (p = 0.327). The between-group treatment differences in response rates were 3.60% [95% confidence interval (CI) = (-5.39%, 12.60%)], which demonstrated the noninferiority of Cutegel. Other secondary efficacy endpoints supported this. No significant differences were observed in the occurrence of adverse events between the two groups.
UNASSIGNED: Similar to Restylane, Cutegel was effective and well tolerated in correcting moderate-to-severe NLFs among the Chinese population.
Nasolabial folds (NLFs) are among the early indicators of facial aging process. In the past, rhytidectomy has been considered a safe procedure, yet it continues to carry risks such as hematoma, skin necrosis, nerve injury, and infection. With the ongoing development of biomaterials including hyaluronic acid (HA), minimally invasive injection procedures for the aesthetic correction of NLFs have become the preferred choice in recent years. The widespread use of HA has resulted in the development of various types of commercial HA fillers, such as Cutegel and Restylane. It is well known that HA filler products produce varying effects, attributable to differences in their components and physical properties. Previous studies have established that Restylane is a safe and effective HA dermal filler for the correction of NLFs. However, there is a lack of studies on both the cosmetic results and safety data for Cutegel in the published literature. Therefore, a randomized, double-blinded, active-controlled clinical trial was conducted at seven Chinese hospitals to evaluate the efficacy and safety of Cutegel for the correction of moderate-to-severe NLFs, compared to the approved Restylane in China. Among the 340 randomized subjects, 170 subjects received Cutegel, and 169 subjects received Restylane. Both groups reported similar improvements in WSRS (the between-group treatment differences in response rates exceeded the prespecified noninferiority margins), and also in other efficacy evaluations. Additionally, the two treatment groups showed similar safety profiles. In summary, Cutegel proved to be well tolerated and effective in this randomized, active-controlled clinical study, demonstrating its noninferiority to Restylane and validating its use as an alternative treatment for Chinese subjects with moderate-to-severe NLFs.
UNASSIGNED: This study was a 52-week, multicenter, randomized, double-blinded, active-controlled clinical trial. Qualified participants with moderate-to-severe NLFs were randomly assigned in a 1:1 ratio to receive Cutegel or Restylane. For the primary efficacy endpoint, the response rate was defined as the percentage of subjects exhibiting an improvement of at least one-point based on blinded evaluation of Wrinkle Severity Rating Scale (WSRS) at 24 weeks after injection. Other secondary efficacy endpoints and treatment-emergent adverse events (TEAEs) were assessed.
UNASSIGNED: Of 340 subjects randomized, 317 completed the week 52 visit. In the per protocol set (PPS), the blinded evaluator-assessed response rates at week 24 were 81.17% for Cutegel versus 77.56% for Restylane (p = 0.327). The between-group treatment differences in response rates were 3.60% [95% confidence interval (CI) = (-5.39%, 12.60%)], which demonstrated the noninferiority of Cutegel. Other secondary efficacy endpoints supported this. No significant differences were observed in the occurrence of adverse events between the two groups.
UNASSIGNED: Similar to Restylane, Cutegel was effective and well tolerated in correcting moderate-to-severe NLFs among the Chinese population.
Nasolabial folds (NLFs) are among the early indicators of facial aging process. In the past, rhytidectomy has been considered a safe procedure, yet it continues to carry risks such as hematoma, skin necrosis, nerve injury, and infection. With the ongoing development of biomaterials including hyaluronic acid (HA), minimally invasive injection procedures for the aesthetic correction of NLFs have become the preferred choice in recent years. The widespread use of HA has resulted in the development of various types of commercial HA fillers, such as Cutegel and Restylane. It is well known that HA filler products produce varying effects, attributable to differences in their components and physical properties. Previous studies have established that Restylane is a safe and effective HA dermal filler for the correction of NLFs. However, there is a lack of studies on both the cosmetic results and safety data for Cutegel in the published literature. Therefore, a randomized, double-blinded, active-controlled clinical trial was conducted at seven Chinese hospitals to evaluate the efficacy and safety of Cutegel for the correction of moderate-to-severe NLFs, compared to the approved Restylane in China. Among the 340 randomized subjects, 170 subjects received Cutegel, and 169 subjects received Restylane. Both groups reported similar improvements in WSRS (the between-group treatment differences in response rates exceeded the prespecified noninferiority margins), and also in other efficacy evaluations. Additionally, the two treatment groups showed similar safety profiles. In summary, Cutegel proved to be well tolerated and effective in this randomized, active-controlled clinical study, demonstrating its noninferiority to Restylane and validating its use as an alternative treatment for Chinese subjects with moderate-to-severe NLFs.
摘要：
■与Restylane®（Restylane，控制)。
■这项研究为期52周，多中心，随机化，双盲,主动对照临床试验。具有中度至重度NLF的合格参与者以1：1的比例随机分配接受Cutegel或Restylane。对于主要疗效终点，应答率定义为在注射后24周时,基于皱纹严重程度评定量表(WSRS)的盲法评估,显示至少1分改善的受试者的百分比.评估其他次要疗效终点和治疗引起的不良事件（TEAE）。
■在随机分组的340名受试者中，317完成了第52周的访问。在每个协议集(PPS)中，24周时盲法评估者评估的缓解率,Cutegel为81.17%,Restylane为77.56%(p=0.327).组间治疗有效率差异为3.60%[95%置信区间(CI)=(-5.39%,12.60%）]，这证明了Cutegel的非劣性。其他次要疗效终点支持这一点。两组患者的不良事件发生率差异无统计学意义。
■类似于Restylane，Cutegel在中国人群中纠正中度至重度NLF方面有效且耐受性良好。
鼻唇沟(NLF)是面部衰老过程的早期指标。在过去,除皱术被认为是一种安全的手术，然而它仍然存在血肿等风险，皮肤坏死,神经损伤,和感染。随着生物材料包括透明质酸（HA）的不断发展，近年来，用于NLF美学矫正的微创注射程序已成为首选。HA的广泛使用导致了各种类型的商业HA填料的开发，如Cutegel和Restylane。众所周知，HA填料产品会产生不同的效果，归因于它们的成分和物理性质的差异。先前的研究已经确定Restylane是用于校正NLF的安全有效的HA真皮填充剂。然而,在已发表的文献中，缺乏关于Cutegel的化妆品结果和安全性数据的研究。因此,一个随机的，双盲,在七家中国医院进行了主动对照临床试验，以评估Cutegel纠正中重度NLF的有效性和安全性，与中国批准的Restylane相比。在340名随机受试者中，170名受试者接受了Cutegel，169名受试者接受了Restylane治疗。两组均报告WSRS有相似的改善（两组间治疗有效率的差异超过了预设的非劣效性边缘），以及其他疗效评估。此外,两个治疗组的安全性相似.总之,Cutegel在该随机分组中被证明具有良好的耐受性和有效性，主动对照临床研究，证明了其对Restylane的非劣效性，并验证了其作为中重度NLF中国受试者的替代治疗的用途。
■这项研究为期52周，多中心，随机化，双盲,主动对照临床试验。具有中度至重度NLF的合格参与者以1：1的比例随机分配接受Cutegel或Restylane。对于主要疗效终点，应答率定义为在注射后24周时,基于皱纹严重程度评定量表(WSRS)的盲法评估,显示至少1分改善的受试者的百分比.评估其他次要疗效终点和治疗引起的不良事件（TEAE）。
■在随机分组的340名受试者中，317完成了第52周的访问。在每个协议集(PPS)中，24周时盲法评估者评估的缓解率,Cutegel为81.17%,Restylane为77.56%(p=0.327).组间治疗有效率差异为3.60%[95%置信区间(CI)=(-5.39%,12.60%）]，这证明了Cutegel的非劣性。其他次要疗效终点支持这一点。两组患者的不良事件发生率差异无统计学意义。
■类似于Restylane，Cutegel在中国人群中纠正中度至重度NLF方面有效且耐受性良好。
鼻唇沟(NLF)是面部衰老过程的早期指标。在过去,除皱术被认为是一种安全的手术，然而它仍然存在血肿等风险，皮肤坏死,神经损伤,和感染。随着生物材料包括透明质酸（HA）的不断发展，近年来，用于NLF美学矫正的微创注射程序已成为首选。HA的广泛使用导致了各种类型的商业HA填料的开发，如Cutegel和Restylane。众所周知，HA填料产品会产生不同的效果，归因于它们的成分和物理性质的差异。先前的研究已经确定Restylane是用于校正NLF的安全有效的HA真皮填充剂。然而,在已发表的文献中，缺乏关于Cutegel的化妆品结果和安全性数据的研究。因此,一个随机的，双盲,在七家中国医院进行了主动对照临床试验，以评估Cutegel纠正中重度NLF的有效性和安全性，与中国批准的Restylane相比。在340名随机受试者中，170名受试者接受了Cutegel，169名受试者接受了Restylane治疗。两组均报告WSRS有相似的改善（两组间治疗有效率的差异超过了预设的非劣效性边缘），以及其他疗效评估。此外,两个治疗组的安全性相似.总之,Cutegel在该随机分组中被证明具有良好的耐受性和有效性，主动对照临床研究，证明了其对Restylane的非劣效性，并验证了其作为中重度NLF中国受试者的替代治疗的用途。
