Abstract
BACKGROUND: VYC-12L is a hyaluronic acid filler to improve skin quality. A prospective study showed safety and effectiveness of VYC-12L for improving cheek skin smoothness and fine lines. OBJECTIVES: To report participant-reported outcomes, subgroup analyses, and physician experience from the prospective study. METHODS: Adults with moderate to severe Allergan Cheek Skin Smoothness (ACSS) scale scores were randomized 2:1 to VYC-12L or control (no treatment with optional treatment). Participant assessments included FACE-Q Satisfaction With Skin, FACE-Q Appraisal of Lines, natural look and feel, the Global Aesthetic Improvement Scale (GAIS), and safety. Subgroup analyses examined ACSS responder rate (≥1-grade improvement from baseline to 1 month). RESULTS: FACE-Q Satisfaction With Skin overall mean scores improved from baseline to 1 month posttreatment by 32.0 and 1.4 in the VYC-12L and control groups, respectively. FACE-Q Appraisal of Lines overall mean scores improved from baseline to 1 month posttreatment by 23.3 and 0.4 in VYC-12L and control, respectively. Treated participants had high median scores (≥9.0) of natural look and feel of their cheek skin. GAIS responder rate was high at Month 1 (85.5%; 95% CI, 79.3%-91.7%) and through Month 6 (83.1%; 95% CI, 76.5%-89.7%). Mean participant-rated pain scores were low (<3). The most common injection site reactions were redness, swelling, and lumps/bumps; most resolved within 3 days. Subgroup analyses showed significant differences in ACSS responder rate between VYC-12L and control groups 1 month posttreatment. Physician injectors reported that VYC-12L was easily injected at the superficial skin and integrated quickly. CONCLUSIONS: VYC-12L treatment produced significant improvements in satisfaction with skin and cheek skin smoothness, as measured by participant-reported outcome measures.