下巴
医学
临床终点
显著性差异
牙科
随机对照试验
口腔正畸科
外科
内科学
解剖
作者
Yun Xie,Qingfeng Li,Hongyi Zhao,Zuoliang Qi,Jiaming Sun,Qian Tan,Dong Li,Zhiqi Hu,Zixi Liu,Smita Chawla
摘要
Abstract Background Individuals with chin retrusion may seek chin and lower jawline aesthetic enhancement. Objectives To evaluate VYC-25L (Juvéderm Volux XC; Allergan Aesthetics, an AbbVie company), a lidocaine-containing injectable hyaluronic acid dermal filler, for chin retrusion correction. Methods In this prospective, Phase 3, multicenter study (NCT04559984), Chinese adults with moderate-to-severe chin retrusion on the China (Allergan) Chin Retrusion Scale (CACRS) and glabella–subnasale–pogonion (G–Sn–Pog) angle <172.5° were randomized 2:1 to VYC-25L (treatment plus optional touch-up 4 weeks later) or no treatment (control). The primary endpoint was change from baseline (CFB) in G–Sn–Pog angle at Week 24. Secondary endpoints included CACRS response (≥1-point improvement), Global Aesthetic Improvement Scale (GAIS) response (improved/much improved), and FACE-Q Satisfaction with Chin score. Procedural pain was rated (0 = none to 10 = worst imaginable); injection-site responses (ISRs) were recorded daily for ≤28 days. Results The mean age of the patient (VYC-25L, n = 97; control, n = 51) was 31.2 years (range, 20-52 years). Mean CFB in G–Sn–Pog angle at Week 24 was 2.97° (VYC-25L) vs 0.09° (control; between-group difference, 3.08° [P < .0001]); improvement was maintained to Week 52. At Week 24, VYC-25L achieved higher responses vs control for CACRS (78.7% vs 18.8%, respectively; rate difference, 60.0%; P < .0001) and GAIS (92.6% vs 4.2%, respectively; rate difference, 88.4%; P < .0001); mean overall FACE-Q Satisfaction with Chin score was 70.4 vs 34.9, respectively. Mean (standard deviation) procedural pain was 2.6 (1.6); most ISRs were mild (41.8%) or moderate (50.0%) in severity. Conclusions In Chinese adults, VYC-25L safely and effectively corrected chin retrusion for at least 1 year. Level of Evidence: 2 (Therapeutic)
科研通智能强力驱动
Strongly Powered by AbleSci AI