Lemdani Mehdi S, Honig Stephanie E, Habarth-Morales Theodore E, Davis Harrison D, Niu Ellen F, Ewing Jane N, Broach Robyn B, Serletti Joseph M, Percec Ivona
Division of Plastic Surgery, University of Pennsylvania, Philadelphia.
JAMA Dermatol. 2025 May 28. doi: 10.1001/jamadermatol.2025.1335.
Multiple botulinum toxin A formulations were approved by the US Food and Drug Administration for treating the glabellar rhytids. A comparative quantitative evaluation of their effects on the glabella has not been conducted.
To provide an objective quantitative assessment of the effect of 4 botulinum toxin A formulations on glabellar strain across using dynamic 3-dimensional photogrammetry.
DESIGN, SETTING, AND PARTICIPANTS: This single-center, double-blind clinical trial, conducted at the University of Pennsylvania Division of Plastic Surgery clinic, randomized 143 female individuals aged 30 to 65 years into 4 arms receiving different botulinum toxin A formulations on day 0 and with follow-up at days 3, 30, 90, and 180. Dynamic 3-dimensional photogrammetry and surveys were collected from March 2022 to June 2023 and analyzed from July 2023 to April 2024.
Participants were randomized 1:1:1:1 into 4 treatment arms: 1 dose of 20 units of onabotulinum toxin A (OBoNT/A); 1 dose of 60 units of abobotulinum toxin A (ABoNT/A); 1 dose of 20 units of prabotulinum toxin A (PBoNT/A); or 1 dose of 20 units of incobotulinum toxin A (IBoNT/A) into the glabellar region (GR).
The primary outcome was change in GR dynamic strain after injection over time. Secondary outcomes included changes in patient-reported satisfaction, the relationship between baseline strain severity and postinjection improvement in strain, and the effect on the strain of the untreated lateral canthal region.
This study recruited 143 female individuals with a mean (SD) age of 43.5 (9.8) years. ABoNT/A and PBoNT/A had the fastest onset at day 3. PBoNT/A and IBoNT/A retained efficacy at day 180 compared with their baseline. Increasing baseline glabellar strain severity resulted in increased improvement with treatment. Lateral canthal region strain increased with decreasing GR strain. PBoNT/A was significantly more effective at day 180 than OBoNT/A. All arms experienced improvement in related FACE-Q module scores up to 90 days.
This randomized clinical trial found that ABoNT/A and PBoNT/A displayed the most rapid onset of effect. The peak effect is similar across all toxins. When measuring strain at approximately 6 months, some toxins remain significant relative to their own baseline or compared with other specific toxins.
ClinicalTrials.gov Identifier: NCT05167864.
多种A型肉毒杆菌毒素制剂已获美国食品药品监督管理局批准用于治疗眉间皱纹。尚未对它们对眉间的影响进行比较定量评估。
使用动态三维摄影测量法对4种A型肉毒杆菌毒素制剂对眉间应变的影响进行客观定量评估。
设计、设置和参与者：这项单中心、双盲临床试验在宾夕法尼亚大学整形外科诊所进行，将143名年龄在30至65岁的女性随机分为4组，在第0天接受不同的A型肉毒杆菌毒素制剂，并在第3、30、90和180天进行随访。从2022年3月至2023年6月收集动态三维摄影测量数据和调查问卷，并于2023年7月至2024年4月进行分析。
参与者按1:1:1:1随机分为4个治疗组：1剂20单位的注射用A型肉毒毒素（OBoNT/A）；1剂60单位的阿柏西普肉毒杆菌毒素A（ABoNT/A）；1剂20单位的普拉博特肉毒杆菌毒素A（PBoNT/A）；或1剂20单位的因卡肉毒杆菌毒素A（IBoNT/A）注射到眉间区域（GR）。
主要结局是注射后眉间动态应变随时间的变化。次要结局包括患者报告的满意度变化、基线应变严重程度与注射后应变改善之间的关系，以及对未治疗的外眦区域应变的影响。
本研究招募了143名女性，平均（标准差）年龄为43.5（9.8）岁。ABoNT/A和PBoNT/A在第3天起效最快。与基线相比，PBoNT/A和IBoNT/A在第180天仍保持疗效。基线眉间应变严重程度增加导致治疗后的改善增加。外眦区域应变随眉间区域应变降低而增加。在第180天，PBoNT/A比OBoNT/A显著更有效。所有组在90天内相关FACE-Q模块评分均有改善。
这项随机临床试验发现，ABoNT/A和PBoNT/A起效最快。所有毒素的峰值效应相似。在大约6个月测量应变时，一些毒素相对于其自身基线或与其他特定毒素相比仍有显著效果。
ClinicalTrials.gov标识符：NCT05167864。
