BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence

Summary

Based on the results of the Phase 2 Study 191622-130 \[NCT02010775\], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.

Timeline

Start

2019-05-16

Primary completion

2020-04-03

Completion

2020-07-02

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs BOTOX® 48U; p <.0001; Percentage Difference 68.8 (95% CI 54.5 to 83.1); Cochran-Mantel-Haenszel NCT03861936 ↗

registry analysis (superiority test); Placebo vs BOTOX® 72U; p <.0001; Percentage Difference 69.6 (95% CI 55.1 to 84.0); Cochran-Mantel-Haenszel NCT03861936 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	48 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	72 iu	Intramuscular

Indications