VYC-20L is Safe and Effective for Improving Volume and Aesthetic Appearance of the Nose in Chinese Adults

Abstract

PurposeSoft tissue filler injection is less invasive than surgical approaches for facial aesthetic improvement. This study evaluated the safety and effectiveness of the soft tissue filler VYC-20L (Juvéderm Voluma® XC) for improvement of volume and aesthetic appearance of the nose in Chinese subjects.Patients and MethodsIn a prospective, multicenter, no-treatment–controlled study in China, adult subjects were randomized 3:1 to receive VYC-20L (treatment group) or have optional treatment delayed by 24 weeks (control group). The treatment group received VYC-20L on day 1 plus optional touch-up at week 8 for suboptimal improvement. The primary effectiveness measure was mean change in nose area volume from baseline to week 24 by digital analysis of three-dimensional (3D) images. Multiple secondary effectiveness and safety measures were assessed.ResultsOf 164 subjects randomized, 162 were treated, and 157 comprised the modified intent-to-treat population (mean age, 31 years; 94% female). In the treatment group, mean VYC-20L volume injected was 1.18 mL (initial treatment) and 0.67 mL (touch-up; n = 46 [38.3%]). VYC-20L achieved significantly larger changes in nose area volume than control at week 24 (2.032 vs ‒0.005 cm3, respectively; p < 0.0001) and greater improvements on the Global Aesthetic Improvement Scale (investigator and subject), Nose Satisfaction Scale, and other 3D measures. No treatment-related adverse events occurred. Most injection site responses were mild/moderate, resolving within 14 days. Mean initial/touch-up treatment procedural pain ratings were less than 3 (0‒10 scale; higher = worse pain).ConclusionVYC-20L is safe and effective for nose augmentation in Chinese adults.