PDF(Pubmed)
Abstract：
UNASSIGNED: Porcine-based dermal injectable collagen is effective for nasolabial fold correction. In the present study, a new dermal injectable collagen, incorporating a novel cross-linking technology and premixed with lidocaine, was introduced. The study aimed to determine the efficacy of the new dermal injectable collagen in improving bilateral nasolabial fold wrinkles, and reducing pain during injection.
UNASSIGNED: This prospective, double-blind, multicenter, parallel-group, randomized trial enrolled participants with moderate-to-severe bilateral nasolabial fold wrinkles from February 2019 to March 2021. Participants were randomly assigned to the test group (new dermal injectable collagen with lidocaine featuring a novel cross-linking technology) or control group (traditionally cross-linked dermal injectable collagen with lidocaine). Participants were monitored for adverse events (AEs), and for pain using the Thermometer Pain Scale (TPS) and a visual analog scale (VAS). Efficacy was measured using the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS).
UNASSIGNED: On the poor or better sides, the 2 groups exhibited a significant decrease in WSRS scores at 4, 12, 24, and 36 weeks after treatment, compared to baseline WSRS scores (all, p < 0.05). Compared to the control group, the test group had a greater decrease in WSRS score (poor or better sides) at 12, 24, 36, and 52 weeks after treatment (all, p < 0.05). A similar observation was also found in the WSRS response rate and GAIS score of the 2 groups. VAS and TPS scores were not significantly different between the 2 groups (p > 0.05), indicating that pain reduction was similar in the 2 groups. All AEs were anticipated AEs associated with facial aesthetic injections, and most recovered within 0 to 30 days without sequelae. There were no differences in AEs between the 2 groups (all, p > 0.05).
UNASSIGNED: The new dermal injectable collagen with lidocaine exhibited better efficacy for correcting nasolabial fold wrinkles compared to the control group. Both relieved pain and produced only transient and tolerable AEs.
UNASSIGNED: This prospective, double-blind, multicenter, parallel-group, randomized trial enrolled participants with moderate-to-severe bilateral nasolabial fold wrinkles from February 2019 to March 2021. Participants were randomly assigned to the test group (new dermal injectable collagen with lidocaine featuring a novel cross-linking technology) or control group (traditionally cross-linked dermal injectable collagen with lidocaine). Participants were monitored for adverse events (AEs), and for pain using the Thermometer Pain Scale (TPS) and a visual analog scale (VAS). Efficacy was measured using the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS).
UNASSIGNED: On the poor or better sides, the 2 groups exhibited a significant decrease in WSRS scores at 4, 12, 24, and 36 weeks after treatment, compared to baseline WSRS scores (all, p < 0.05). Compared to the control group, the test group had a greater decrease in WSRS score (poor or better sides) at 12, 24, 36, and 52 weeks after treatment (all, p < 0.05). A similar observation was also found in the WSRS response rate and GAIS score of the 2 groups. VAS and TPS scores were not significantly different between the 2 groups (p > 0.05), indicating that pain reduction was similar in the 2 groups. All AEs were anticipated AEs associated with facial aesthetic injections, and most recovered within 0 to 30 days without sequelae. There were no differences in AEs between the 2 groups (all, p > 0.05).
UNASSIGNED: The new dermal injectable collagen with lidocaine exhibited better efficacy for correcting nasolabial fold wrinkles compared to the control group. Both relieved pain and produced only transient and tolerable AEs.
摘要：
■基于猪的皮肤可注射胶原对于鼻唇沟矫正是有效的。在本研究中,一种新的皮肤注射胶原蛋白，结合一种新的交联技术，并与利多卡因预混，被介绍了。该研究旨在确定新的皮肤可注射胶原蛋白在改善双侧鼻唇沟皱纹中的功效，减少注射过程中的疼痛。
■这个前景，双盲,多中心，平行组，随机试验纳入了2019年2月至2021年3月患有中度至重度双侧鼻唇沟皱纹的参与者.参与者被随机分配到测试组（具有新型交联技术的利多卡因新型皮肤可注射胶原蛋白）或对照组（传统上是利多卡因交联的皮肤可注射胶原蛋白）。监测参与者的不良事件（AE），并使用温度计疼痛量表（TPS）和视觉模拟量表（VAS）进行疼痛。使用皱纹严重程度评定量表（WSRS）和整体美学改善量表（GAIS）测量功效。
■在较差或较好的方面，两组在治疗后4、12、24和36周表现出WSRS评分的显著下降，与基线WSRS得分相比(所有，p<0.05)。与对照组相比,试验组在治疗后12、24、36和52周（所有，p<0.05)。在2组的WSRS反应率和GAIS评分中也发现了类似的观察结果。两组间VAS和TPS评分差异无统计学意义(p>0.05),表明疼痛减轻在2组中相似.所有AE都是与面部美学注射相关的预期AE，大多数在0至30天内恢复，没有后遗症。两组之间的AE没有差异(所有，p>0.05)。
■与对照组相比，具有利多卡因的新型皮肤可注射胶原蛋白在纠正鼻唇沟皱纹方面表现出更好的功效。两者均缓解了疼痛，并且仅产生短暂且可耐受的AE。
■这个前景，双盲,多中心，平行组，随机试验纳入了2019年2月至2021年3月患有中度至重度双侧鼻唇沟皱纹的参与者.参与者被随机分配到测试组（具有新型交联技术的利多卡因新型皮肤可注射胶原蛋白）或对照组（传统上是利多卡因交联的皮肤可注射胶原蛋白）。监测参与者的不良事件（AE），并使用温度计疼痛量表（TPS）和视觉模拟量表（VAS）进行疼痛。使用皱纹严重程度评定量表（WSRS）和整体美学改善量表（GAIS）测量功效。
■在较差或较好的方面，两组在治疗后4、12、24和36周表现出WSRS评分的显著下降，与基线WSRS得分相比(所有，p<0.05)。与对照组相比,试验组在治疗后12、24、36和52周（所有，p<0.05)。在2组的WSRS反应率和GAIS评分中也发现了类似的观察结果。两组间VAS和TPS评分差异无统计学意义(p>0.05),表明疼痛减轻在2组中相似.所有AE都是与面部美学注射相关的预期AE，大多数在0至30天内恢复，没有后遗症。两组之间的AE没有差异(所有，p>0.05)。
■与对照组相比，具有利多卡因的新型皮肤可注射胶原蛋白在纠正鼻唇沟皱纹方面表现出更好的功效。两者均缓解了疼痛，并且仅产生短暂且可耐受的AE。
