Efficacy and Safety of PrabotulinumtoxinA in Subjects With Benign Masseteric Hypertrophy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase 3 Trial and Open-Label Extension Study

Author:

Seok Joon1,Koh Young Gue1,Hong Jun Ki1,Yun So Hye2,Kim Da Hye2,Son Hyung Seok3,Choi Sun Young4,Yoo Kwang Ho4,Lee Yang Won35,Kim Beom Joon1

Affiliation:

1. Department of Dermatology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea;

2. Daewoong Pharmaceutical, Co., Ltd., Seoul, South Korea;

3. Department of Dermatology, Konkuk University School of Medicine, Seoul, South Korea;

4. Department of Dermatology, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University College of Medicine, Gwangmyeong-si, Gyeonggi-do, South Korea;

5. Research Institute of Medical Science, Konkuk University, Seoul, South Korea

Abstract

BACKGROUND Despite the widespread use of botulinum toxin (BTX) injection for the treatment of masseter muscle hypertrophy (MMH), there is no standard treatment option. OBJECTIVE We report the efficacy and safety for BTX in MMH over a period of 48 weeks. METHODS In double-blinded, placebo-controlled phase 3 trials, 180 patients (randomized 1:1) received treatment with placebo (normal saline) or prabotulinumtoxinA (48 units). Masseter muscle thickness (at maximal clenching and resting positions), 3D imaging analysis, and masseter muscle hypertrophy scale grades were analyzed at each time point. After the 24-week CORE study, all patients who met the same criteria of the CORE study at week 24 (n = 114) received only prabotulinumtoxinA, regardless of previous treatment, for an additional 24 weeks (48 weeks in total) for the open-label extension study. RESULTS The largest differences in mean and percent changes from baseline in masseter muscle thickness were observed at 12 weeks, and there were significant differences between the 2 groups at all time points (all p < .001). The effect was independent of the number of injections. No serious adverse event was observed. CONCLUSION PrabotulinumtoxinA could effectively ameliorate MMH without major complications.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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