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Patient-reported Outcomes in Chinese Subjects Treated with OnabotulinumtoxinA for Crow's Feet Lines
Yan Wu1,2, Chengxin Li1,2, Julia Garcia1,2
1Dr. Wu is with Peking University First Hospital in Beijing, China. Dr. Li is with the Chinese PLA General Hospital in Beijing, China.
Background:
Crow's feet lines (CFLs) can impact the emotional state, self-perception, and consciousness regarding appearance of patients.
Objective:
This study sought to assess patient-reported outcomes after onabotulinumtoxinA treatment for CFLs among Chinese subjects.
Methods:
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.
Results:
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 (P<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 (P≤0.01).
Conclusion:
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.
Trial Registration:
ClinicalTrials.gov identifier no. NCT02195687.
