Volumizing hyaluronic acid filler for midface volume deficit: 2-year results from a pivotal single-blind randomized controlled study

Abstract

Background: Hyaluronic acid (HA) gels are commonly used to correct age-related midface volume deficit (MVD), yet the Food and Drug Administration has not specifically approved them for this purpose.

Objective: To study the safety and effectiveness of a new 20-mg/mL HA gel (VYC-20L) specifically formulated and optimized for mid-face volumizing.

Methods and materials: A multicenter, single-blind, controlled study randomized 235 subjects aged 35 to 65 with MVD to a treatment group and 47 to a no-treatment control group. Responders were defined as subjects who achieved improvement of 1 point or more on the validated 6-point Mid-Face Volume Deficit Scale (MFVDS) at 6 months as rated live by two blinded independent evaluators. The primary endpoint required a 70% or greater treatment group response and a statistically significant difference (p < .001) between the treatment and control group responder rates.

Results: The primary endpoint was met, with 85.6% of the treatment group improving by 1 point or more on the MFVDS at month 6 and a statistically significant difference (p < .001) between the treatment and control group responder rates. Subjects tolerated VYC-20L well, with no unanticipated adverse device effects. Nearly half of subjects maintained correction for 24 months.

Conclusion: VYC-20L is safe and effective for age-related MVD, with correction lasting up to 2 years.

© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.