An Evaluation of VYC‐17.5L for the Treatment of Marionette Lines: A Prospective, Open‐Label, Postmarketing Study

ABSTRACT Background Marionette lines are a feature of the aging face, descending from the oral commissures towards the jaw. VYC‐17.5 L is a dermal filler that contains 17.5 mg/mL of hyaluronic acid (HA) and lidocaine (3 mg/mL); it is intended for the treatment of skin depressions. VYC‐17.5 L has been shown to be safe and effective in different conditions, but there is a lack of published literature on its effectiveness in marionette lines. Aims This 12‐month prospective, open‐label, post‐marketing study evaluated the effectiveness and safety of the injectable HA filler VYC‐17.5 L for the improvement of marionette lines. Methods Adults (≥ 18 years) with mild‐to‐severe marionette lines on the validated Allergan Marionette Line Scale (AMLS) received VYC‐17.5 L on Day 1 with optional touch‐up on Day 14. The primary endpoint was proportion of participants with ≥ 1‐point change in AMLS from baseline at Month 1 (M1). Secondary endpoints were investigator‐ and participant‐rated Global Aesthetic Improvement Scale (GAIS), FACE‐Q satisfaction with facial appearance, and appraisal of lines: marionette. Safety was assessed throughout. Results A total of 83 participants completed the study; 69.9% of participants had ≥ 1‐point change in AMLS at M1. Investigator and participant GAIS showed improvement. Both FACE‐Q scores significantly improved from baseline ( p < 0.0001). A significant volume improvement was seen and maximized at M1. Most participant‐reported injection site reactions were mild or moderate and resolved within 8 days; 14 subjects reported adverse device effects, with the most common being pain, which resolved within 8 days. Conclusion This prospective, open‐label study showed that VYC‐17.5 L effectively improved marionette lines and was well tolerated.