A Multicenter Phase II Study Evaluating the Safety and Efficacy of Botulax in Asian Patients with Benign Masseteric Hypertrophy

Background: Benign masseteric hypertrophy (BMH) is a condition in which the thickness of the masseter muscle is increased, resulting in jawline prominence with an undesirable cosmetic appearance. Botulinum toxin type A (BTA) injection is a promising treatment option, but its effective dose remains debated. Methods: Adults older than 19 diagnosed with BMH through visual examination and palpation related to a masseter muscle prominence were selected, and 80 patients were randomly assigned into five groups (placebo group and four groups with different doses of BTA: 24 U, 48 U, 72 U, or 96 U, on both sides of the jaw) and treated with placebo or BTA once at their baseline visit. During each follow-up, the treatment efficacy was evaluated with ultrasound examination of the masseter muscle, three-dimensional facial contour analysis, visual evaluation by the investigator, and patient satisfaction evaluation. Results: The mean age of the 80 patients was 42.7 ± 9.98 years; 68.75% were women. The mean change in masseter muscle thickness during the maximum clenching state after 12 weeks of drug administration compared with baseline in the 24-U, 48-U, 72-U, and 96-U groups were −2.33 ± 0.41 mm, −3.35 ± 0.42 mm, −2.86 ± 0.42 mm, and −3.79 ± 0.42 mm, respectively. All treatment groups showed a statistically significant decrease compared with placebo. Regarding subjective satisfaction, all treatment groups, except the 24-U group at 4 weeks, showed higher satisfaction than the placebo group during all visits. No significant adverse events were noted. Conclusion: BTA administration of at least 48 U for BMH is more cost-effective than high-dose units and has a low risk of side effects. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.