IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From Two Randomized, Double-Blind, Placebo-Controlled, Phase III Studies.

Abstract

Two randomized, double-blind, placebo-controlled, Phase III studies of incobotulinumtoxinA for treating upper facial lines (UFL; combination of glabellar frown lines [GFL], horizontal forehead lines [HFL] and lateral canthal lines [LCL]) were conducted in the US (ULTRA I: NCT04594213) and Germany (ULTRA II: NCT04622254). To evaluate safety and efficacy of simultaneous intramuscular injections for UFL. Longer-term safety and efficacy were assessed in open-label extension periods (OLEX). Healthy participants (≥18 years) with moderate-to-severe GFL, HFL and symmetrical LCL at maximum contraction on the five-point Merz Aesthetics Scales (MAS) were randomized 2:1:1 to receive up to 64 Units of incobotulinumtoxinA in the main period (MP) for each trial. Treatment groups were: UFL, GFL & HFL (ULTRA I), LCL (ULTRA II) and placebo. Primary efficacy endpoints were the proportions of GFL, HFL and LCL responders, defined as a MAS score for the respective area of 0 (no) or 1 (mild) and ≥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 endpoint (p < 0.0001) and key secondary endpoints (p < 0.0001). OLEX results were consistent with those seen in the MP. No new safety findings were identified. In ULTRA I and ULTRA II, safety and efficacy of incobotulinumtoxinA for the simultaneous treatment of moderate-to-severe UFL were demonstrated, with significant improvements across all primary and secondary endpoints versus placebo.