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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

CARRUTHERS, JEAN MD, FRCS (C), FRC (Ophth)1,*; CARRUTHERS, ALASTAIR MA, BM, BCH, FRCPC, FRCP (Lon)1,†; MONHEIT, GARY D. MD1,‡,§; DAVIS, PAULA G. PHD1,¶

doi: 10.1111/j.1524-4725.2010.01797.x
ORIGINAL ARTICLES
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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.

CONCLUSION 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.

The authors acknowledge statistical support from Ethica Clinical Research, Inc. (Montréal, Quebec, Canada). 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. Funding for editorial support was provided by Allergan, Inc., Irvine, CA. Writing and editorial assistance was provided by Paula G. Davis, PhD, of Health Learning Systems, Parsippany, NJ. The authors received research grant support from Allergan, Inc. for this study and for manuscript preparation.

1Departments of *Ophthalmology and Visual Sciences and Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; Departments of Dermatology and §Ophthalmology, University of Alabama at Birmingham, Birmingham, Alabama; Health Learning Systems, Parsippany, New Jersey.

Address correspondence and reprint requests to: Jean Carruthers, MD, FRCS (C), FRC (Ophth), Jean Carruthers Cosmetic Surgery, 943 West Broadway, Suite 820, Vancouver, BC, Canada V5Z4E1, or e-mail: drjean@carruthers.net

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