AboutSkin Dermatology and DermSurgery, PC, Greenwood Village, Colorado.
Private Practice, Boca Raton, Florida.
Dermatol Surg. 2022 Nov 1;48(11):1191-1197. doi: 10.1097/DSS.0000000000003585. Epub 2022 Oct 5.
OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL).
To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL.
A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction.
OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days.
A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.
肉毒毒素 A 已被证实可安全有效地治疗上脸皱纹，包括额纹（FHL）、眉间纹（GL）和鱼尾纹（CFL）。
评估肉毒毒素 A 对上脸皱纹（UFL）的疗效与患者报告的心理影响和满意度之间的相关性。
对 4 项关键性 3 期临床试验（肉毒毒素 A 对比安慰剂治疗 FHL±GL、FHL+GL±CFL、CFL 和 CFL+GL，治疗时间≤180 天）的数据进行汇总分析，评估 Allergan 面部皱纹量表（FAS）在第 30 天的≥1 级严重程度改善（应答者）。采用面部皱纹量表结果问卷（FLO-11）、面部皱纹满意度问卷（FLSQ）和患者自评外貌满意度（SASA）评估应答者的外貌相关心理影响和满意度。
根据主要研究关注点（FHL、GL 或 CFL），肉毒毒素 A 患者分别为 921、921 和 833 例，接受安慰剂的患者为 786 例。大多数患者为女性、白种人，年龄 45 至 50 岁（中位数）。在 150 天内，≥42%的 FHL、≥43%的 GL 和≥32%的 CFL 患者为肉毒毒素 A 应答者。应答者报告称，在 150 天内，他们的外貌相关心理影响（FLO-11）得到了改善，且满意度很高（FLSQ 和 SASA）。
肉毒毒素 A 治疗 UFL 时，若能实现≥1 级改善，则可获得有临床意义的疗效，且能长期改善患者报告的心理影响和满意度。
