Aesthet Surg J. 2024 Nov 15;44(12):1330-1340. doi: 10.1093/asj/sjae131.
RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced with PEARL (precipitation-free extraction and activity-preserving refined liquid) manufacturing technology, which yields a potent, complex-free formulation.
In the READY-1 study, efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction were examined.
Adults with moderate to severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades improvement from baseline on concurrent investigator (glabellar line investigator live assessment; GL-ILA) and participant (glabellar line subject live assessment; GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for participants scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Participant satisfaction and treatment-emergent adverse events (TEAEs) were reported.
Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, n = 199) vs 0% (placebo, n = 67; P < .001). Month 1 investigator-reported none or mild responder rate was 96.3% (RelaBoNT-A) vs 4.5% (placebo; P < .001). GL-ILA scores remained higher with RelaBoNT-A (23.6% [none or mild]; 58.1% [≥1-grade improvement]) vs placebo (1.5%; 10.4%, respectively) through Month 6 (P < .001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end of study). Participants reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild.
A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.
RelabotulinumtoxinA（RelaBoNT-A，高德美，乌普萨拉，瑞典）是一种创新的即用型液体肉毒毒素 A，采用 PEARL（无沉淀提取和活性保护精制液体）制造技术生产，可提供强效、无杂质的配方。
在 READY-1 研究中，评估了单次 RelaBoNT-A 治疗眉间线矫正的疗效和安全性结果。
患有中重度眉间线的成年人按 3:1 比例随机接受 RelaBoNT-A（50U）或安慰剂治疗，为期 6 个月，这是一项多中心、双盲、3 期临床试验。主要终点（在第 1 个月、最大皱眉时评估）包括复合≥2 级应答，定义为同时使用研究者（眉间线研究者现场评估；GL-ILA）和参与者（眉间线受试者现场评估；GL-SLA）严重程度量表评估的基线改善≥2 级（美国终点），以及参与者评分 0（无）或 1（轻度）的研究者报告应答者比例（仅 GL-ILA 量表；欧盟终点）。报告了参与者满意度和治疗出现的不良事件（TEAEs）。
总体而言，297 名成年人被随机分配并接受治疗。第 1 个月的复合≥2 级应答率为 82.9%（RelaBoNT-A，n=199），而安慰剂组为 0%（n=67；P<.001）。第 1 个月的研究者报告无或轻度应答率为 96.3%（RelaBoNT-A），而安慰剂组为 4.5%（P<.001）。通过第 6 个月，RelaBoNT-A 组的 GL-ILA 评分仍保持较高水平（23.6%[无或轻度]；58.1%[≥1 级改善]），而安慰剂组分别为 1.5%和 10.4%（P<.001）。在 Kaplan-Meier 分析中，75%的患者在 169 天时（研究结束时）仍显示 GL-ILA 和 GL-SLA 较基线改善。参与者报告从第 1 天（39%）开始出现效果，并对自然外观的结果表示满意（96.8%；第 1 个月）。RelaBoNT-A 相关 TEAEs 发生率较低（3.6%），通常为轻度。
单次 RelaBoNT-A 治疗有效，并显示出良好的安全性。RelaBoNT-A 在 6 个月的研究期间提供了显著的眉间线严重程度改善、高满意度、起效迅速和持久疗效。
