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.