A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years

Abstract

Background: Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD).

Objectives: The effectiveness of Juvéderm Voluma XC was examined from the patient perspective.

Methods: Patients with moderate to severe age-related MVD (N = 235) received Juvéderm Voluma XC. At quarterly follow-up visits for 2 years, patients rated treatment outcomes on the Global Aesthetic Improvement Scale (GAIS), overall satisfaction with facial appearance, satisfaction with midfacial regions, achievement of treatment goal, Look and Feel of the Midface (LAFM), and Self-Perception of Age (SPA). Patients recorded treatment-site responses in 30-day diaries.

Results: At 6 months and 2 years after treatment, 92.8% and 79.0% of patients, respectively, rated their cheek volume as improved/much improved on the GAIS. Improvement in satisfaction with facial appearance was noted by 89.8% of patients at 6 months and 75.8% at 2 years. Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24. Treatment goals were achieved by 67.8% of patients at 6 months and 49.0% at 2 years. Patients reported looking, on average, 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses were tenderness, swelling, firmness, and lumps/bumps; most were mild to moderate in severity and lasted ≤2 weeks.

Conclusions: Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years.

Level of evidence: 4 Therapeutic.

Trial registration: ClinicalTrials.gov NCT00978042.

© 2015 The American Society for Aesthetic Plastic Surgery, Inc.

Figures

Figure 1.

Diagram showing the midface treatment areas.

Figure 2.

Percentage of patients who rated themselves as improved or much improved on the Global Aesthetic Improvement Scale.

Figure 3.

Percentage of patients with improved scores for overall satisfaction with facial appearance since baseline.

Figure 4.

Percentage of patients rating scores of 7 to 10 on the assessment of the look and feel of the midface. (A) Cheeks make me look older than I want to look; (B) Cheeks make me look tired, even when I am not; (C) Cheeks make me look unattractive; (D) Cheeks make me look sad, even when I am not. Scores ranged from 0 to 10, where 0 = not at all, 5 = somewhat, and 10 = very much. Significant improvements in mean score were noted in all categories at 6 and 12 months and in the categories of older and tired at 24 months. *Clinically significant change from baseline in mean satisfaction score (defined a priori as change of ≥3 points).

Figure 5.

Aesthetic outcomes with Juvéderm Voluma XC for this 48-year-old woman before treatment (A, B), at 6 months (C, D), and at 24 months (E, F) after treatment with 6.3 mL of Juvéderm Voluma XC in the midface.

Figure 6.

Aesthetic outcomes with Juvéderm Voluma XC for this 59-year-old woman before treatment (A, B), at 6 months (C, D), and at 24 months (E, F) after treatment with 8.9 mL of Juvéderm Voluma XC in the midface.

Figure 7.

Percentage of patients reporting that their perceived age was younger than their chronological age, older, or the same compared with baseline at 6 (A), 12 (B), and 24 (C) months after treatment.