Table 1.
Overview of High-Dose BoNTA Studies
| Product | Placebo controlled (Y/N) | Maximum dose (X registration dose) | Duration | Volume per injection | Dose studied | Primary endpoint |
|---|---|---|---|---|---|---|
| Abobotulinum (N = ~400) | Yes | 2.5 | 36 weeks (~252 days) | 0.05 mL | 50U (US label), 75U, 100U, and 125U | Composite response at 30 days (investigator AND patient both report a score of ≤1 in glabellar line severity AND ≥2-grade improvement from baseline) |
| Incobotulinum (N = 151) | No | 3.75 | 180 days (~28 weeks) | 0.05 mL | 20U (US label), 50U, and 75U | Return to baseline severity |
| Onabotulinum (N = 225) | Yes | 4.0 | 48 weeks (336 days) | 0.05 mL | 20U (US label), 40U, 60U, and 80U | Proportion with ≥1-grade improvement from baseline at week 24 (investigator) |
BoNTA, botulinum neurotoxin type A.