Wu Yan, Li Chengxin, Garcia Julia, Baradaran Sarah
Dr. Wu is with Peking University First Hospital in Beijing, China. Dr. Li is with the Chinese PLA General Hospital in Beijing, China.
Drs. Garcia and Baradaran are with Allergan Aesthetics, an AbbVie Company, in Irvine, California.
J Clin Aesthet Dermatol. 2021 Oct;14(10):27-31.
Crow's feet lines (CFLs) can impact the emotional state, self-perception, and consciousness regarding appearance of patients.
This study sought to assess patient-reported outcomes after onabotulinumtoxinA treatment for CFLs among Chinese subjects.
A five-month, double-blind, randomized, parallel-group, placebo-controlled Phase III clinical study was conducted including Chinese adults with moderate-to-severe CFLs at maximum smile. Subjects were randomized 3:1 to 24 U of onabotulinumtoxinA or placebo and completed the 11-item Facial Line Outcomes (FLO-11) questionnaire and Facial Line Satisfaction Questionnaire (FLSQ) at baseline; on Days 8, 15, and 30; and monthly thereafter until Day 150. Item-level and/or domain analyses for the FLO-11 and FLSQ were conducted.
Of 417 treated subjects, 316 received onabotulinumtoxinA and 101 received placebo. For all 10 validated stand-alone FLO-11 items, there was a significantly greater proportion of responders in the onabotulinumtoxinA group versus placebo (<0.001) at Day 30 that was maintained through Day 150. Significant improvements at Day 30 were reported for all FLSQ items and the FLSQ Follow-up Impact Domain (≤0.01).
FLO-11 and FLSQ data indicated high satisfaction and significant improvements in appearance-related and emotional impacts through Day 150 in patients treated with onabotulinumtoxinA for moderate-to-severe CFLs in Chinese subjects.
ClinicalTrials.gov identifier no. NCT02195687.
鱼尾纹会影响患者的情绪状态、自我认知以及对外表的在意程度。
本研究旨在评估中国受试者接受A型肉毒毒素治疗鱼尾纹后患者报告的结局。
进行了一项为期五个月的双盲、随机、平行组、安慰剂对照的III期临床研究，纳入最大程度微笑时存在中度至重度鱼尾纹的中国成年人。受试者按3:1随机分为接受24 U A型肉毒毒素或安慰剂组，并在基线、第8天、第15天和第30天，以及此后每月直至第150天完成11项面部皱纹结局（FLO-11）问卷和面部皱纹满意度问卷（FLSQ）。对FLO-11和FLSQ进行了项目级和/或领域分析。
在417例接受治疗的受试者中，316例接受了A型肉毒毒素治疗，101例接受了安慰剂治疗。对于所有10项经过验证的独立FLO-11项目，在第30天时，A型肉毒毒素治疗组的应答者比例显著高于安慰剂组（<0.001），并持续至第150天。所有FLSQ项目和FLSQ随访影响领域在第30天时均报告有显著改善（≤0.01）。
FLO-11和FLSQ数据表明，在中国受试者中，接受A型肉毒毒素治疗中度至重度鱼尾纹的患者在第150天时对外表相关和情绪影响的满意度较高且有显著改善。
ClinicalTrials.gov标识符：NCT02195687。
