Joseph John, Sudimac Vladimir, Mersmann Sabine, Kerscher Martina
Aesthet Surg J. 2025 Feb 18;45(3):293-304. doi: 10.1093/asj/sjae222.
Two randomized, double-blind, placebo-controlled, Phase III studies of incobotulinumtoxinA for treating upper facial lines (UFLs; ie, a combination of glabellar frown lines [GFLs], horizontal forehead lines [HFLs], and lateral canthal lines [LCLs]) were conducted in the United States (ULTRA I: NCT04594213) and Germany (ULTRA II: NCT04622254).
The aim of this study was to evaluate the safety and efficacy of simultaneous intramuscular injections for UFLs. Longer-term safety and efficacy were assessed in open-label extension periods.
Healthy participants (≥18 years) with moderate-to-severe GFLs, HFLs, and symmetric LCLs at maximum contraction on the 5-point Merz Aesthetics Scales were randomized 2:1:1 to receive up to 64 units of incobotulinumtoxinA in the main period for each trial. Treatment groups were: UFLs, GFLs, and HFLs (ULTRA I), LCLs (ULTRA II), and placebo. Primary efficacy endpoints were the proportions of GFL, HFL, and LCL responders, defined as a Merz Aesthetics Scale score for the respective area of 0 (no) or 1 (mild) and a ≥2-grade improvement from baseline to Day 30, as assessed by both investigator and participant.
Overall, 362 and 368 participants received treatment in ULTRA I and ULTRA II, respectively. In both studies, incobotulinumtoxinA treatment was significantly more effective than placebo with respect to the primary endpoints (P < .0001) and key secondary endpoints (P < .0001). The open-label extension period results were consistent with those seen in the main period. No new safety findings were identified.
In ULTRA I and ULTRA II, the safety and efficacy of incobotulinumtoxinA for the simultaneous treatment of moderate-to-severe UFLs were demonstrated, with significant improvements across all primary and secondary endpoints vs placebo.
在美国（ULTRA I：NCT04594213）和德国（ULTRA II：NCT04622254）开展了两项关于因卡波糖毒素A治疗上面部皱纹（UFLs；即眉间皱眉纹[GFLs]、水平额头纹[HFLs]和外眦纹[LCLs]的组合）的随机、双盲、安慰剂对照III期研究。
本研究的目的是评估同时进行肌肉注射治疗UFLs的安全性和有效性。在开放标签延长期评估了长期安全性和有效性。
在5分制默茨美学量表上，最大收缩时具有中度至重度GFLs、HFLs和对称LCLs的健康参与者（≥18岁）以2:1:1的比例随机分组，在每项试验的主要阶段接受高达64单位的因卡波糖毒素A。治疗组分别为：UFLs组、GFLs组和HFLs组（ULTRA I）、LCLs组（ULTRA II）和安慰剂组。主要疗效终点是GFL、HFL和LCL反应者的比例，定义为各自区域的默茨美学量表评分为0（无）或1（轻度），且从基线到第30天改善≥2级，由研究者和参与者评估。
总体而言，分别有362名和368名参与者在ULTRA I和ULTRA II中接受了治疗。在两项研究中，就主要终点（P < .0001）和关键次要终点（P < .0001）而言，因卡波糖毒素A治疗显著比安慰剂更有效。开放标签延长期的结果与主要阶段的结果一致。未发现新的安全问题。
在ULTRA I和ULTRA II中，证明了因卡波糖毒素A同时治疗中度至重度UFLs的安全性和有效性，与安慰剂相比，所有主要和次要终点均有显著改善。
