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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

CARRUTHERS, ALASTAIR MA, BM, BCh, FRCPC, FRCP(LON)1; CARRUTHERS, JEAN MD, FRCS(C), FRC(OPHTH)2; MONHEIT, GARY D. MD3; DAVIS, PAULA G. PHD4; TARDIE, GREG PHD4

doi: 10.1111/j.1524-4725.2010.01705.x
ORIGINAL ARTICLES
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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.

CONCLUSION 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: alastair@carruthers.net

© 2010 by the American Society for Dermatologic Surgery, Inc.
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