Reduction of masseter muscle prominence after treatment with onabotulinumtoxinA: Primary results from a randomized phase 2 study.

IF 12.8 1区医学 Q1 DERMATOLOGY Journal of the American Academy of Dermatology Pub Date : 2024-11-09 DOI:10.1016/j.jaad.2024.10.064

Jean Carruthers, Steven Liew, Jason K Rivers, Shyi-Gen Chen, Shannon Humphrey, Grace Pan, Beta Bowen, Elisabeth Lee, Mitchell F Brin

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Abstract

Background: OnabotA is used to treat masseter muscle prominence (MMP).

Objective: To assess the safety and efficacy of OnabotA for MMP in a randomized study.

Methods: This 12-month, multicenter, double-blind, placebo-controlled, phase 2 study randomized adults (18-50 years of age) with marked/very marked bilateral MMP (≥4 on the Masseter Muscle Prominence Scale [MMPS]) to OnabotA (24, 48, 72, or 96 U) or placebo; retreatment occurred at day 180 if MMPS ≥4. Lower facial volume at day 90 was measured using Vectra 3-dimensional photography. Safety assessments included computed tomography and dental exams. Evaluations occurred monthly through day 360.

Results: Among 187 randomized subjects, significant lower facial volume reductions and percentage of responders (MMPS grade ≤3) were greater with OnabotA versus placebo at day 90 (P < .001 and ≤.008, respectively). Similar efficacy was observed with retreatment. No dose-related safety trends or clinically relevant changes in the mandible or teeth occurred. Localized impact on smile was reported with 96 U OnabotA (n = 4).

Limitations: Limited sample size per individual treatment group.

Conclusion: OnabotA administered in 1 or 2 treatments over 1 year was associated with significant reductions in masseter muscle volume and MMP severity, with an acceptable safety profile.

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使用鬼臼毒素A治疗后咀嚼肌突出减少：随机第二阶段研究的主要结果。

背景：目的：在一项随机研究中评估奥那巴妥珠单抗（onabotulinumtoxinA）治疗MMP的安全性和有效性：在一项随机研究中评估奥那保妥适（onabotulinumtoxinA）治疗MMP的安全性和有效性：这项为期12个月、多中心、双盲、安慰剂对照的2期研究将双侧MMP明显/非常明显（颌下肌突出量表[MMPS]≥4）的成人（18-50岁）随机分配到onabotulinumtoxinA（24、48、72或96 U）或安慰剂中；如果MMPS≥4，则在第180天进行再治疗。使用 Vectra 三维摄影测量第 90 天的面部下部容积。安全性评估包括计算机断层扫描和牙科检查。每月进行一次评估，直至第 360 天：结果：在 187 名随机受试者中，第 90 天时，使用奥诺博定注射液与安慰剂相比，面部下部体积明显缩小，应答者（MMPS 等级≤3）的比例更高（P < .001 和 ≤ .008）。再治疗也观察到类似的疗效。下颌骨或牙齿未出现与剂量相关的安全性趋势或临床相关变化。据报道，使用96 U阿糖胞苷对微笑有局部影响（4人）：局限性：每个治疗组的样本量有限：结论：在一年内分1次或2次治疗使用奥那巴妥珠单抗，可显著减少颌下肌肉体积和MMP严重程度，且安全性可接受。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the American Academy of Dermatology 医学-皮肤病学

CiteScore

8.60

自引率

5.80%

发文量

2023

审稿时长

49 days

期刊介绍： The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.