Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial

BACKGROUND: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid-formulation) was the first to assess satisfaction with FACE-Q after glabellar-line (GL) injection. OBJECTIVES: To evaluate patient-satisfaction with ASI for GL treatment using three FACE-Q scales: facial appearance, psychological well-being, and aging appearance. METHODS: Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL, with 6-month follow-up. RESULTS: Significantly greater least squares (LS) mean changes from baseline were associated with ASI treatment (N=125) versus placebo (N=59) for satisfaction with facial appearance at all visits until Day 148 (5 months; p<0.0001-0.0037); psychological well-being at all visits (p<0.0001-0.0279); and aging appearance at all visits except Day 148 (p<0.0001-0.0409). At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102). Maximal LS mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigator's live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r=-0.41 and r=-0.36 [both p<0.0001], respectively). CONCLUSIONS: Significant improvements in patient satisfaction with aging and facial appearance, and importantly psychological well-being, were demonstrated with ASI using FACE-Q scales up to 5-6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.