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

ABSTRACT:

Background

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).

Objectives

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.

Methods

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 incobotulin

SUBMITTER: Joseph J 

PROVIDER: S-EPMC11834979 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature