Jason K Rivers1, Vince Bertucci, William McGillivray, Channy Muhn, Nathan Rosen, Nowell Solish, Barry M Weichman, Sarah Wheeler, Selena R Daniels, Conor J Gallagher. 1. *Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; †Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; ‡Project Skin MD Ltd., Vancouver, British Columbia, Canada; §Division of Dermatology, McMaster University, Hamilton, Ontario, Canada; ‖Division of Dermatology, Women's College Hospital, Toronto, Ontario, Canada; ¶Peloton Advantage, Parsippany, New Jersey; #Allergan, Inc., Irvine, California.
Abstract
BACKGROUND: Patient satisfaction with treatment is an important outcome in facial aesthetic medicine. OBJECTIVE: To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and crow's feet lines (CFL) using the validated Facial Line Satisfaction Questionnaire (FLSQ). METHODS: In this randomized double-blind study, subjects with moderate/severe GL and CFL receivedonabotulinumtoxinA (20 U, GL; 24 U, CFL) or placebo. Over 120 days, the following were assessed: satisfaction, achievement of treatment expectations, satisfaction with duration of treatment (FLSQ), severity of GL and CFL (Facial Wrinkle Scale [FWS]), and aesthetic improvement (Global Aesthetic Improvement Scale). RESULTS:Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group (n = 60) compared with placebo (n = 57) for GL (81.7% vs 0%; p < .001). Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days. Achievement of treatment expectations (86.7%; Day 60), satisfaction (81.7%; Day 60), and satisfaction with the duration of treatment (61.6%; Day 90) were significantly better with onabotulinumtoxinA than placebo (p < .001) for GL and CFL combined. Efficacy (FWS) and aesthetic improvement were observed in most subjects at Days 30 and 60, respectively. CONCLUSION:High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined.
RCT Entities:
BACKGROUND:Patient satisfaction with treatment is an important outcome in facial aesthetic medicine. OBJECTIVE: To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and crow's feet lines (CFL) using the validated Facial Line Satisfaction Questionnaire (FLSQ). METHODS: In this randomized double-blind study, subjects with moderate/severe GL and CFL received onabotulinumtoxinA (20 U, GL; 24 U, CFL) or placebo. Over 120 days, the following were assessed: satisfaction, achievement of treatment expectations, satisfaction with duration of treatment (FLSQ), severity of GL and CFL (Facial Wrinkle Scale [FWS]), and aesthetic improvement (Global Aesthetic Improvement Scale). RESULTS: Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group (n = 60) compared with placebo (n = 57) for GL (81.7% vs 0%; p < .001). Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days. Achievement of treatment expectations (86.7%; Day 60), satisfaction (81.7%; Day 60), and satisfaction with the duration of treatment (61.6%; Day 90) were significantly better with onabotulinumtoxinA than placebo (p < .001) for GL and CFL combined. Efficacy (FWS) and aesthetic improvement were observed in most subjects at Days 30 and 60, respectively. CONCLUSION: High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined.
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