Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study

Abstract

BackgroundHyaluronic 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.MethodsSubjects 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).ResultsOf 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.ConclusionVoluma™ 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.

Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study

“…Consequently, based on the photographic assessment, these subjects could not improve any further. This could explain the fact that the responder rate on photographic evaluation was lower than the responder rate on live assessment in the current study and other published clinical data 9,13,25,26…”

“…The authors believe that for this reason, the published rates of volume augmentation and global esthetic improvement were higher than in the current study. It should also be noted that the rating scales and the effectiveness end points used in these studies were not exactly the same 13,25,26…”

A Comprehensive Approach to Multimodal Facial Aesthetic Treatment

“…The overall mean injected volume of VYC-20L for midface regions in this study (3.1 mL) was approximately half that used in previous trials (6.65 mL and 5.1 mL, respectively). 8,30 In the current study, the mean injection volume in the zygomaticomalar area (V1/V2 region) was 1.4 mL total compared with 2.4 mL in the pivotal trial. 8 Similarly, in the current study, mean injection H A R M O N Y : I N J E C T I O N T E C H N I Q U E S volume in the anteromedial region (V3 region) was 1.2 mL compared with 2.1 mL in the pivotal trial.…”

Dermal Fillers and Volume Enhancers for Facial Rejuvenation

“…This means that the aesthetic provider will have a good idea of the level of correction of the product right away (most HA products absorb water over time which means that the level of correction changes). The reduced tendency to swell and the more efficient cross-linking of Voluma mean that the product will last longer (18 months) ( Allergan, 2013 ;Callan et al, 2013 ).…”