Joseph John H, Eaton Laura L, Robinson James, Pontius Allison, Williams Edwin F
J Drugs Dermatol. 2016 Dec 1;15(12):1544-1549.
To evaluate the duration of effect of a single dose of 120 units of abobotulinumtoxinA for the treatment of moderate to severe glabellar lines.
Investigator-initiated, prospective, multi-center, open-label study.
This open-label trial of thirty subjects with moderate to severe glabellar lines at maximum frown was per- formed at 2 private plastic surgery clinics. 120 units of abobotulinumtoxinA was injected in 5 equal aliquots (24 units each) into each of 5 injection sites in the glabellar complex. Investigator and subject assessments of wrinkle severity at maximum frown and repose using 4-point scales and adverse events were conducted. Follow-up was monthly for up to 11 months.
The median duration of response for all subjects, as assessed by the investigator, was 150 days (95% CI: 120, 180). The median duration of response was 165 days (95% CI: 90, 180) for subjects with Grade 2 (Moderate) wrinkles at baseline and 75 days (95% CI: 30, 120) for subjects with Grade 3 (Severe) wrinkles at baseline. Overall, 76.7% of subjects had a duration of ≥ 120 days. At the end of study (day 300) 9/16 (53%) of subjects who were Grade 3 at baseline still rated themselves as not returning to Grade 3, demonstrating ongoing improvement. Adverse events were mild and transient. There were no events of lid or brow ptosis.
The 120 units of abobotulinumtoxinA were significantly effective in reducing glabellar lines in subjects with Grade 2 (Moderate) wrinkles at baseline for a longer duration than the reported 85 days in the FDA Phase III randomized, placebo-controlled clinical studies using a standard 50 unit dose. Subject satisfaction was high. There was no increase in the incidence of adverse events with this higher dose. J Drugs Dermatol. 2016;15(12):1544-1549.
评估单剂量120单位阿柏毒素A治疗中度至重度眉间纹的疗效持续时间。
研究者发起的前瞻性、多中心、开放标签研究。
这项开放标签试验在2家私立整形外科诊所对30名最大皱眉时具有中度至重度眉间纹的受试者进行。将120单位阿柏毒素A以5等份（每份24单位）注射到眉间复合体的5个注射部位。研究者和受试者使用4分制量表对最大皱眉和静止时的皱纹严重程度以及不良事件进行评估。随访每月进行一次，最长持续11个月。
研究者评估所有受试者的中位反应持续时间为150天（95%可信区间：120, 180）。基线时为2级（中度）皱纹的受试者中位反应持续时间为165天（95%可信区间：90, 180），基线时为3级（重度）皱纹的受试者中位反应持续时间为75天（95%可信区间：30, 120）。总体而言，76.7%的受试者反应持续时间≥120天。在研究结束时（第300天），基线时为3级的16名受试者中有9名（53%）仍将自己评为未恢复到3级，表明仍在改善。不良事件轻微且短暂。没有眼睑或眉毛下垂事件。
120单位阿柏毒素A在减少基线时为2级（中度）皱纹的受试者眉间纹方面显著有效，且持续时间长于FDA III期随机、安慰剂对照临床研究中使用标准50单位剂量所报告的85天。受试者满意度高。该较高剂量并未增加不良事件的发生率。《药物皮肤病学杂志》。2016年；15(12):1544 - 1549。
