Steven Dayan MD1 | John Joseph MD2 | Amir Moradi MD, MBA3 |
Z. Paul Lorenc MD, FACS4 | Kyle Coleman MD5 | Glynis Ablon MD, FAAD6 |
Joely Kaufman-Janette MD7 | Sue Ellen Cox MD8 | Andrew Campbell MD9 |
Girish Munavalli MD, MHS, FACMS10 | Inna Prygova MD11
Abstract
Background: Previous studies indicate that the efficacy and durability of a single
AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be
enhanced with increasing dose, while safety outcomes remain consistent with those
of the licensed dose (50 U).
Aims: Evaluation of subject-reported indicators of treatment efficacy, satisfaction,
and psychological well-being with ABO dose escalation.
Methods: A Phase 2, 36-week,
multicenter, randomized, dose-ranging, double-blind, placebo-controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject-assessed
improvement in line severity of ≥1-grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE-Q™ appraisal of lines, psychological well-being and age, and subject satisfaction.
Results: The study included 399 subjects (88.2% were female). Respective responder
rates (≥1-grade improvement) with ABO 50–125 U doses ranged between 96.3%–100% at Week 4, 65.0%–67.9% at Week 24, and 33.8%–44.4% at Week 36. GAIS responder rate and FACE-Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well-being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses.
Conclusions: A single ABO treatment (dosed at 50–125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well-being.
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