Multicenter, randomized, parallel-group study of the safety and effectiveness of onabotulinumtoxinA and hyaluronic acid dermal fillers (24-mg/ml smooth, cohesive gel) alone and in combination for lower facial rejuvenation.
BACKGROUND
Combination treatment with toxins and fillers is the standard regimen in facial rejuvenation. Systematic studies of botulinum toxin alone and in combination with hyaluronic acid (HA) have not, however, been conducted in the lower face.


OBJECTIVE
To evaluate safety and effectiveness and compare combination treatment with onabotulinumtoxinA and a 24-mg/mL smooth, cohesive HA gel filler with either treatment alone for rejuvenation of the perioral area and lower face in female subjects.


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 included perioral, lip fullness, and oral commissure assessments and scores on the Cosmetic Improvement and Global Aesthetic Improvement Scales. Adverse events were monitored throughout.


RESULTS
For all end points and most time points, subjects treated with onabotulinumtoxinA plus the 24-mg/mL cohesive gel had greater improvement from baseline than subjects treated with onabotulinumtoxinA or the 24-mg/mL cohesive gel filler alone.


CONCLUSIONS
Based on a range of end points, onabotulinumtoxinA and 24-mg/mL cohesive HA gel treatments are effective and safe when either alone or in combination to rejuvenate the lower face. Combination therapy is superior to either modality used alone.
Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada. alastair@carruthers.net
Alastair
A
Carruthers
Jean
J
Carruthers
Gary D
GD
Monheit
Paula G
PG
Davis
Greg
G
Tardie
D000328:Adult; D001672:Biocompatible Materials; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D004359:Drug Therapy, Combination; D005145:Face; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007267:Injections; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D011446:Prospective Studies; D012060:Rejuvenation; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
D001672:Biocompatible Materials; D005782:Gels; C526061:Juvederm Ultra; C526062:Juvederm Ultra Plus; D009465:Neuromuscular Agents; D006820:Hyaluronic Acid; D019274:Botulinum Toxins, Type A