Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study
Authors Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD
Received 21 November 2012
Accepted for publication 24 December 2012
Published 20 March 2013 Volume 2013:6 Pages 81—89
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Peter Callan,1 Greg J Goodman,2 Ian Carlisle,3 Steven Liew,4 Peter Muzikants,5 Terrence Scamp,6 Michael B Halstead,7 John D Rogers7
1Peter Callan Plastic Surgery, Geelong, VIC, 2Dermatology Institute of Victoria, South Yarra, VIC, 3Erase Skin Rejuvenation Specialists, Malvern, VIC, 4Shape Clinic and Medispa, Darlinghurst, NSW, 5Ada Cosmetic Medicine, Glebe, NSW, 6Esteem Beauty and Day Spa, Main Beach, QLD, 7Allergan Medical Affairs, Gordon, ACT, Australia
Background: Hyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects.
Methods: Subjects received treatment with Juvéderm™ Voluma™ to the malar area, based on the investigators' determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS).
Results: Of the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma™ at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma™, with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported.
Conclusion: Voluma™ is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.
Keywords: hyaluronic acid, dermal fillers, volume deficit, volume deficiency, mid-face, malar
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