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- W2073071921 abstract "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.To study the safety and effectiveness of a new 20-mg/mL HA gel (VYC-20L) specifically formulated and optimized for mid-face volumizing.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.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.VYC-20L is safe and effective for age-related MVD, with correction lasting up to 2 years." @default.
- W2073071921 created "2016-06-24" @default.
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- W2073071921 date "2013-11-01" @default.
- W2073071921 modified "2023-10-16" @default.
- W2073071921 title "Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: 2-Year Results from a Pivotal Single-Blind Randomized Controlled Study" @default.
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- W2073071921 doi "https://doi.org/10.1111/dsu.12343" @default.
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