J Drugs Dermatol. 2021 Sep 1;20(9):988-995. doi: 10.36849/jdd.6130.
Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals.
To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume. Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and ≥2-grade improvement from baseline concurrently on both ILA and SSA).
Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, P<0.001, 91–92% had none-or-mild GL severity, and 95–100% had a ≥1-grade GL severity improvement. A ≥1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (P<0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated.
Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 months’ duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction. J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130.
增加 abobotulinumtoxinA（aboBoNT-A）的复溶和注射体积可为美容医疗专业人员提供更多选择。
使用新的复溶和注射体积，评估 aboBoNT-A 治疗中重度眉间纹（GL）与安慰剂相比的疗效和安全性。
在这项为期 6 个月、III 期、随机、双盲研究中，18-64 岁的受试者接受 aboBoNT-A50U（N=224）或安慰剂（N=77）治疗，将 300U 小瓶中的药物复溶至 3mL 后，在眉间区域进行五次 0.1mL（10U）注射。评估包括起效时间、研究者（ILA）和受试者（SSA）评估的 GL 严重程度、受试者满意度、美学改善和安全性。主要终点是第 1 个月时的复合 2 级应答（最大皱眉时 GL 严重程度为无或轻度，同时 ILA 和 SSA 均较基线改善≥2 级）。
中位起效时间为 2 天，34%的受试者在第 1 天报告起效。第 1 个月，aboBoNT-A 的复合 2 级应答率为 65.8%，安慰剂组为 0%，P<0.001，91-92%的受试者 GL 严重程度为无或轻度，95-100%的受试者 GL 严重程度改善≥1 级。直至第 6 个月，aboBoNT-A 治疗的受试者中仍有 46-56%持续出现 GL 严重程度改善≥1 级（P<0.001 与安慰剂相比）。6 个月内，美学改善和受试者满意度一直较高，aboBoNT-A 治疗耐受性良好。
使用每注射部位 0.1mL（10U）aboBoNT-A 治疗 GL 的安全性和疗效得到了证实，起效迅速，疗效持续长达 6 个月。严重程度改善伴随持续的美学改善和受试者满意度。《皮肤病药物杂志》。2021;20（9）：988-995. doi：10.36849/JDD.6130.
