Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Medical Department, Arta Pharmed Company, Tehran, Iran.
J Cosmet Dermatol. 2022 Jun;21(6):2398-2406. doi: 10.1111/jocd.14939. Epub 2022 Apr 9.
Injection of botulinum toxin for cosmetic purposes is a well-established practice.
This study was conducted to compare the safety and efficacy of Dyston (investigational biosimilar abobotulinumtoxinA) with Dysport (abobotulinumtoxinA, Ipsen) in the treatment of moderate-to-severe glabellar lines.
Out of 193 screened subjects, 126 volunteers with moderate-to-severe glabellar lines fulfilling eligibility criteria were randomized in a 1:1 ratio to receive either an intramuscular injection of 40-60 units of Dyston or Dysport . The primary objective was to test the non-inferiority of Dyston compared with Dysport as measured by the percentage of volunteers who achieved no or mild glabellar lines at maximum frown assessed by the physicians based on the Glabellar Line Severity Score (GLSS) at Day 30. Secondary endpoints included the improvement in the glabellar lines at maximum frown and rest states at Days 14, 60, 90, and 120 as well as the side effects of the treatment.
Response rates at maximum frown were 75.44% (43/57) in the Dyston group and 76.67% (46/60) in the Dysport group on Day 30 (p value: 0.88, 95% CI: -14.24 to 16.70, diff: 1.23) as per-protocol set, and were 75.81% (47/62) and 76.19 (48/63) (p value: 0.96, 95% CI: -14.59 to 15.35, diff: 0.3) in the Dyston and the Dysport groups, respectively, based on modified intention to treat population. Adverse events were similar in both groups and mostly mild and well-tolerated.
Treatment of moderate-to-severe glabellar lines with Dyston was effective, tolerable, and non-inferior compared with Dysport .
出于美容目的而注射肉毒毒素是一种成熟的做法。
本研究旨在比较 Dyston（研究性生物类似物 abobotulinumtoxinA）与 Dysport（abobotulinumtoxinA，Ipsen）治疗中重度眉间纹的安全性和疗效。
在 193 名筛选出的受试者中，126 名符合入选标准的中重度眉间纹志愿者按 1:1 的比例随机接受 40-60 单位的 Dyston 或 Dysport 肌内注射。主要目的是通过医生根据第 30 天的 Glabellar Line Severity Score (GLSS)评估最大皱眉时无或轻度眉间纹的志愿者比例，测试 Dyston 与 Dysport 相比的非劣效性。次要终点包括在第 14、60、90 和 120 天最大皱眉和休息状态时眉间纹的改善情况以及治疗的副作用。
根据方案设定，在第 30 天，Dyston 组最大皱眉时的应答率为 75.44%（43/57），Dysport 组为 76.67%（46/60）（p 值：0.88，95%CI：-14.24 至 16.70，差值：1.23），在符合方案人群中，Dyston 组和 Dysport 组的应答率分别为 75.81%（47/62）和 76.19%（48/63）（p 值：0.96，95%CI：-14.59 至 15.35，差值：0.3）。基于修改后的意向治疗人群。两组的不良反应相似，大多为轻度且耐受良好。
与 Dysport 相比，Dyston 治疗中重度眉间纹有效、耐受且非劣效。
