Derek Jones1, Diane K Murphy. 1. Department of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; Skin Care Laser Physicians of Beverly Hills, Los Angeles, California.
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.
RCT Entities:
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.
Authors: Guk Jin Jeong; Hye Sung Han; Ga Ram Ahn; Eun Jung Ko; Sun Young Choi; Keyong Ho Lee; Beom Joon Kim Journal: Dermatol Ther Date: 2019-04-29 Impact factor: 2.851