Τετάρτη 22 Ιανουαρίου 2020

VYC-25L Hyaluronic Acid Injectable Gel is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.

VYC-25L Hyaluronic Acid Injectable Gel is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.:

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VYC-25L Hyaluronic Acid Injectable Gel is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.

Aesthet Surg J. 2020 Jan 21;:

Authors: Ogilvie P, Benouaiche L, Philipp-Dormston WG, Belhaouari L, Gaymans F, Sattler G, Harvey C, Schumacher A

Abstract

BACKGROUND: Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.

OBJECTIVE: Evaluate safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.

METHODS: This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive single repeat treatment during months 18-24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.

RESULTS: Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18 and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. Safety profile was as expected.

CONCLUSIONS: Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.

PMID: 31960896 [PubMed - as supplied by publisher]

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