Multicenter, randomized, parallel-group study of onabotulinumtoxinA and hyaluronic acid dermal fillers (24-mg/ml smooth, cohesive gel) alone and in combination for lower facial rejuvenation: satisfaction and patient-reported outcomes.
BACKGROUND
Patient-reported outcomes (PROs) are important assessment benchmarks after aesthetic procedures. Systematic studies of PROs have not been conducted in the lower face.


OBJECTIVE
To study satisfaction and other PROs after treatment of the lower face with onabotulinumtoxinA and a 24-mg/mL smooth, cohesive hyaluronic acid (HA) gel filler, alone or in combination.


METHODS
Ninety female participants aged 35 to 55 were randomized to one of three groups: 24-mg/mL cohesive gel alone (n=30), onabotulinumtoxinA alone (n=30), or the combination (n=30). Effectiveness outcomes were investigator- and participant-rated satisfaction and the participant Self-Perception of Age (SPA) and participant-rated Look and Feel of the Lips and Mouth (LAF) questionnaires. Participants maintained a 14-day diary to record severity of treatment site responses.


RESULTS
All treatments resulted in significant improvements from baseline at all end points and on all PRO measures. For all measures and most time points, the 24-mg/mL cohesive gel treatment groups experienced greater improvements than onabotulinumtoxinA alone. Participant-rated severity of treatment-related reactions was mainly mild and transient.


CONCLUSIONS
OnabotulinumtoxinA and 24-mg/mL cohesive HA gel treatments, used alone or in combination for lower face rejuvenation, resulted in significant improvement in investigator- and participant-reported outcomes.
Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada. drjean@carruthers.net
Jean
J
Carruthers
Alastair
A
Carruthers
Gary D
GD
Monheit
Paula G
PG
Davis
D000328:Adult; D001672:Biocompatible Materials; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D005145:Face; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D017060:Patient Satisfaction; D012060:Rejuvenation; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
D001672:Biocompatible Materials; D009465:Neuromuscular Agents; D006820:Hyaluronic Acid; D019274:Botulinum Toxins, Type A