IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.

ABSTRACT

BACKGROUND: In clinical practice, different upper facial areas are commonly treated together. OBJECTIVE: To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period. MATERIALS AND METHODS: In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of "none" or "mild" or a ≥1-point improvement in MAS scores. RESULTS: A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection. CONCLUSION: IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number 2011-005887-20).