AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study

Objective: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in correction moderate-to-severe glabellar lines. Design: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study. Methods: Adults with lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, placebo. Primary endpoint was week 4 composite ≥2-grade responder rate among those achieving severity score 0 (none) 1 (mild) maximum frown, evaluated using concurrent investigator subject assessments. Secondary endpoints included ≥1-grade improvement, duration effect, reporting treatment-emergent adverse events (TEAEs). Results: Overall, 399 subjects were (88.2% female). Week 80.0% (50 U), 88.8% (75 90.0% (100 U) 95.1% (125 versus 2.6% placebo (P<0.001). Responder (≥1-grade) ranged between 53% 69% 24 18% 31% 36. Median time (weeks) to return baseline severity/worse, scoring (mild), 32.3 34.3 36.0 36.6 23.7 (placebo). ABO-related TEAEs reported 4% (80% mild). No seroconversion neutralizing antibodies seen. Conclusion: A treatment provided rapid effective improvements line all doses. Higher doses tended demonstrate elevated response rates longer effect. All well-tolerated low TEAE incidence. J Drugs Dermatol. 2021;20(9):980-987. doi:10.36849/JDD.6263