Efficacy and Safety of a Novel Botulinum Toxin A for Masseter Reduction: A Randomized, Double-Blind, Placebo-Controlled, Optimal Dose-Finding Study

Abstract

BACKGROUND A wide lower face and a square jaw are considered esthetic problems, particularly in Asia. OBJECTIVE To investigate the optimal dose of a novel botulinum toxin (prabotulinum toxin A) for treating masseteric hypertrophy. METHODS Ninety subjects with masseteric hypertrophy were randomly divided into 5 groups and treated with placebo (A, normal saline) or prabotulinum toxin A (B: 24, C: 48, D: 72, and E: 96 units). Photography, ultrasonography, and 3-dimensional imaging were performed before and after injection at baseline and at 4, 8, 12, and 16 weeks after treatment. The participants also rated their satisfaction. RESULTS Masseter thickness significantly reduced in all groups at 12 weeks, compared with that in the placebo group. A dose-dependent reduction in masseter thickness was observed at the resting and maximal clenching positions. Sonography and 3-dimensional imaging revealed a gradual reduction in masseter thickness and volume, respectively, during the first 12 weeks. Despite being slightly effective, a dose of 24 units might be insufficient for resolving square face problems. Patients in Group E reported discomfort during jaw movement. CONCLUSION Prabotulinum toxin A could effectively improve lower face contour without major complications, with an optimal dose of 48 to 72 units, followed by reinjection after 12 weeks.