Subject-Reported Outcomes Over 2 Years With a Volumizing Hyaluronic Acid Filler For Mid-Face Volume Deficit

Objective: To examine the effectiveness of a volumizing hyaluronic acid (HA) filler (Allergan, Inc.) from the subject perspective.

Methods: Fifteen North American investigational sites used a volumizing HA filler to treat 235 subjects who had moderate to severe age-related mid-face volume deficit.  At quarterly follow-up visits for 2 years the subjects rated the treatment outcomes on the Global Aesthetic Improvement Scale, overall satisfaction with facial appearance, satisfaction with mid-facial regions, look and feel of the mid-face, achievement of treatment goal, and self-perception of age.  Subjects also completed 30-day diaries to record common treatment site responses.

Results: At 6 months after treatment, 93% of subjects rated their cheek volume as improved or much improved on the Global Aesthetic Improvement Scale, and a majority of subjects still felt that way at 2 years.  Improvement in satisfaction with facial appearance over baseline was noted by 90% of subjects at 6 months and 76% of subjects at 2 years.  Satisfaction with the outer and lower cheek areas improved from 23% at baseline to 86% at 6 months, and cheek bone projection improved from 30% to 85%.  At baseline a majority of subjects rated their cheeks as making them look tired, sad, unattractive, and older than they wanted to look.  Statistically significant improvements were noted for all of these categories at 6 months.  Two-thirds of subjects rated their treatment goals as having been met at 6 months, and almost half agreed that the goals were still attained at 2 years.  At every timepoint through 2 years a majority of subjects perceived themselves as looking younger than they did at baseline.  On average, subjects reported looking 5 years younger at 6 months and 3 years younger at 2 years.  The most common treatment site responses reported were tenderness, swelling, firmness, and lumps/bumps, most of which were mild to moderate in severity and lasted 2 weeks or less.

Conclusions: The volumizing HA filler for age-related mid-face volume deficit is effective and well-tolerated from the subject perspective, with results lasting up to 2 years.