An Evaluation of VYC-17.5L for Forehead Contouring: A Prospective, Open-Label, Post-Marketing Study

Abstract

Background: Forehead contouring can be achieved using injectable fillers. VYC-17.5L is a filler containing 17.5 mg/mL of hyaluronic acid (HA) with lidocaine (3 mg/mL) for the treatment of skin depressions due to premature aging. Prior studies have demonstrated the safety and efficacy of VYC-17.5L in nasolabial folds, lips, and radial cheek lines, but little has been published on the effectiveness of VYC17.5L for forehead contouring. Aims: This prospective, open-label, post-marketing study conducted in France evaluated the effectiveness and safety of the HA injectable filler VYC-17.5L for use in forehead contouring. Methods: Adults (≥ 18 years) with irregularities of forehead contouring received VYC-17.5L in the forehead on Day 1 with an optional touch-up on Day 14. Effectiveness was assessed via investigator-rated Global Aesthetic Improvement Scale (GAIS) of “improved” or “much improved” from baseline at month 1 (M1). Secondary endpoints included participant-rated GAIS and FACE-Q Satisfaction with Facial Appearance. Injection site reactions (ISRs) and adverse device effects (ADEs) were assessed throughout the study. Results: Eighty subjects completed the study. The primary endpoint was met: 97.5% of participants showed improvement on the investigator GAIS. Participant GAIS scores were also improved. FACE-Q scores significantly improved from baseline (p < 0.0001) and were sustained through month 12. Most ISRs were mild or moderate and resolved in ~1 week. Nine subjects (11%) reported ADEs, with the majority being mild or moderate; the most common ADE was pain, which resolved in < 15 days. Conclusion: VYC-17.5L was well tolerated and effective for improving forehead contouring, as demonstrated by improvements in investigator- and participant-rated measures.