Bertucci Vince, Humphrey Shannon, Carruthers Jean, Solish Nowell, Muhn Channy, Swift Arthur, Rubio Roman G, Shears Gill, Rosen Nathan
*Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; Departments of †Dermatology and Skin Science, and ‡Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; §Faculty of Medicine, McMaster University, Hamilton, Ontario, Canada; ‖Dermetics, Burlington, Ontario, Canada; ¶The Westmount Institute of Plastic Surgery, Montreal, Québec, Canada; #Clinical Development Department, Revance Therapeutics, Inc., Newark, California; **Write on Target Ltd., Leighton Buzzard, United Kingdom.
Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.
Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002).
To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity.
In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks.
Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup.
40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.
注射用达昔布妥毒素A（RT002）是一种研究性A型肉毒毒素。已发表的2期数据表明，与20单位的A型肉毒毒素相比，40单位的达昔布妥毒素A具有显著更高的缓解率和显著更长的缓解持续时间（中位24周），并且总体上似乎安全且耐受性良好（www.clinicaltrials.gov NCT02303002）。
评估这些疗效和安全性结果是否受基线眉间纹严重程度的影响。
在这项2期、随机、剂量范围、平行组、双盲、多中心研究中，最大皱眉时具有中度或重度眉间纹的受试者被随机分配至20单位、40单位或60单位的达昔布妥毒素A、20单位的A型肉毒毒素或安慰剂组。研究人员对疗效进行了≥24周的评估。
根据基线眉间纹严重程度分层的符合方案人群（n = 191）的数据（125例中度，66例重度）表明，无论基线眉间纹是中度还是重度，40单位的达昔布妥毒素A相对于20单位的A型肉毒毒素在一系列疗效指标上均保持临床优势。由于每个亚组规模有限，未完成统计学评估。
40单位的达昔布妥毒素A在中度和重度眉间纹中似乎均比20单位的A型肉毒毒素具有临床疗效优势，在重度眉间纹中观察到的优势更大。
