Aesthetic Improvement of Glabellar Lines with Liquid RelabotulinumtoxinA Treatment in a 12-Month Randomized Controlled Study

BACKGROUND: RelabotulinumtoxinA (relaBoNT-A) is a novel, complex-free, ready-to-use liquid BoNT-A for aesthetic use. METHODS: This double-blind, Phase 3b study evaluated long-term (12-month) efficacy, satisfaction, safety, and time to onset of effect of relaBoNT-A for glabellar lines (GLs). Subjects were randomized 3:1 to a single dose of 50 U relaBoNT-A or placebo. RESULTS: RelaBoNT-A was superior to placebo at Month 1 based on subject-reported Global Aesthetic Improvement Scale (GAIS) responder rates at maximum frown (primary endpoint), 92.9% (92/99 subjects) versus 9.1% (3/33 subjects), p<0.001. GAIS response after relaBoNT-A treatment remained high through Months 9 (42.7%) and 12 (37.8%), as did investigator-assessed GL severity (GL-ILA) ≥1-grade improvement at maximum frown at Months 6 (57.4%), 9 (28.1%), and 12 (12.2%). GAIS and GL-ILA showed onset of effect in 39.8% and 43.9% of relaBoNT-A-treated subjects within 1 day. Investigators reported increased confidence in dosing consistency with the ready-to-use product at baseline (98.0% relaBoNT-A vs. 100% placebo), and that they could achieve consistent (99.0% vs. 64.5%) and natural-looking results (98.0% vs. 64.5%) at Month 1. Subject satisfaction was higher for relaBoNT-A than placebo from Day 1 through Month 12. Two-thirds of subjects preferred treatment with relaBoNT-A to prior treatments with powder BoNT-As. Treatment-related adverse events (all mild) occurred in 8.1% of subjects. CONCLUSIONS: RelaBoNT-A showed rapid onset of effect from Day 1, with duration of effect through Month 6 for most subjects, and beyond 6 months for some. Injectors were highly satisfied with product usability, and subjects remained satisfied through Month 12. Treatment was well tolerated.