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

Abstract

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: dermal fillers; hyaluronic acid; malar; mid-face; volume deficiency; volume deficit.

Figures

Figure 1

Study subjects with a pre-treatment MFVDS grade of 3, 4, and 5 respectively, as evaluated by the physician investigator. Abbreviation: MFVDS, Midface Volume deficient Scale.

Figure 2

Study subject with a pre-treatment MFVDS grade of 4 who maintained a ≥1 grade improvement from baseline/pre-treatment state for the duration of the 104 week study after Voluma™ treatment at weeks 0 and 4 only, as evaluated using the MFVDS (physician investigator assessment) and the GAIS (independent physician investigator and subject evaluations). Abbreviations: GAIS, Global Aesthetic Improvement Scale; MFVDS, Midface Volume Deficit Scale.

Figure 3

(A) Proportion of subject with ≥1 point improvement from baseline in MFVDS score, (“MFVDS responder”) as evaluated by the physician investigators (all subjects). No subject received further study treatment after week 0 or 4. Numbers in parentheses are the sample size at each visit. (B) Proportion of responders from the sub-group of 45 subjects who completed the study and who received no further treatment with the study product after the week 0 or 4. Abbreviation: MFVDS, Midface Volume Deficit Scale.

Figure 4

(A) Proportion of subjects with ≥1 point improvement in their pre-treatment appearance based on GAIS (“GAIS responder”), as evaluated by the physician investigators. No subject received further study treatment after week 0 or 4. Numbers in parentheses are the sample size at each visit. (B) Proportion of subjects from the subgroup of 45 who completed the study and who received no further treatment after week 0 or 4 with ≥1 point improvement in their pre-treatment appearance, based on the GAIS (“GAIS responder”) at week 104, as evaluated by the physician investigators. Abbreviation: GAIS, Global Aesthetic Improvement Scale.

Figure 5

(A) Proportion of subjects with ≥1 point improvement in their pre-treatment appearance based on GAIS (“GAIS responder”), as evaluated by the subjects. No subject received further study treatment after week 0 or 4. Numbers in parentheses are the sample size at each visit. (B) Proportion of subjects from the sub-group of 45 who completed the study and who received no further treatment after week 0 or with a ≥1 point improvement in their pre-treatment appearance, based on the GAIS (“GAIS responder”) at week 104, as self-evaluated by the subjects. Abbreviation: GAIS, Global Aesthetic Improvement Scale.

Figure 6

Treatment Satisfaction of the Study Subjects (all observed subjects).

Figure 7

Study Treatment Recommendation. Note: Study Subject’s response to the following question: “Would you recommend Voluma™to others”? (all observed subjects).