Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines.

Two Phase III randomized controlled trials were conducted in the US (ULTRA I) and Germany (ULTRA II) to investigate the efficacy of incobotulinumtoxinA for simultaneous treatment of upper facial lines (UFLs: glabellar frown lines [GFLs], horizontal forehead lines [HFLs] and lateral canthal lines [LCLs]). Healthy adults with moderate to severe GFLs, HFLs, and symmetrical LCLs were enrolled. Participants were randomized 2:1:1 to three groups: placebo, UFLs, and GFLs & HFLs (ULTRA I) or LCLs (ULTRA II). All participants received up to 64 units of incobotulinumtoxinA in the main period (MP) and were eligible for two additional treatment cycles in the open-label extensions (OLEX). Endpoints included participant- and investigator-assessed Global Aesthetic Improvement Scale (pGAIS and iGAIS, respectively; any improvement defined as ≥ +1 score versus baseline) and the percentage of GFL, HFL, and LCL responders, defined as ≥ 1-grade improvement in Merz Aesthetics Scale (MAS) score versus baseline at maximum contraction. For pGAIS at Day 30, the proportion of participants with any improvement was very high (> 97%) across all three treatment cycles. iGAIS results were similar and slightly higher than pGAIS results. In the MP, investigator and participant MAS assessments were similar, with > 78% of participants showing a positive treatment response for UFLs up to Day 90; responses in the placebo groups remained low at all time points (< 13%). MAS results in the OLEX were consistent with the MP. Additional endpoints, including pGAIS, iGAIS, and MAS scores, corroborate prior ULTRAI/II findings and demonstrate the efficacy of incobotulinumtoxinA for simultaneous treatment of UFLs. ULTRA I: NCT04594213; ULTRA II: NCT04622254.