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

Summary: In this level-1 study, 2 Phase III randomized, double-blind, placebo-controlled studies (ULTRA I in the U.S. and ULTRA II in Germany) evaluated the safety and efficacy of incobotulinumtoxinA for simultaneous treatment of moderate-to-severe upper facial lines—glabellar frown lines, horizontal forehead lines, and lateral canthal lines. Participants received up to 64 units of incobotulinumtoxinA or placebo, with treatment success defined by a ≥2-grade improvement on the Merz Aesthetics Scale. In both trials, incobotulinumtoxinA showed significantly greater efficacy than placebo across all endpoints (P < .0001), with consistent results in open-label extension periods and no new safety concerns.

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