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.
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.
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.
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.
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.
Drs. Alastair and Jean Carruthers are consultants and investigators and receive honoraria from Allergan, Inc. They are also consultants and investigators for Merz Pharmaceuticals and Solstice Neurosciences. Dr. Gary Monheit is a consultant and clinical investigator for Allergan, Galderma, Medicis, Merz Pharmaceuticals, and Revance Therapeutics.
1Departments of Dermatology and Skin Science
2Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada
3Departments of Dermatology and Ophthalmology, University of Alabama at Birmingham, Birmingham, Alabama
4Health Learning Systems, Parsippany, New Jersey
Address correspondence and reprint requests to: Alastair Carruthers, MA, BM, BCh, FRCPC, FRCP(Lon), University of British Columbia, 943 West Broadway, Suite 820, Vancouver, BC, Canada V5Z 4E1, or e-mail: firstname.lastname@example.org