A Prospective, Open-Label, Multicenter, Real-World Study of VYC-17.5L Hyaluronic Acid Dermal Filler in the Lips

Abstract

BACKGROUND: Hyaluronic acid (HA) injectable gels are used to define, enhance, and volumize facial regions, such as the lips, a common treatment area. OBJECTIVES: To evaluate the effectiveness and safety of the HA injectable gel Juvéderm Volift (Allergan, Aesthetics, an AbbVie Company Irvine, CA) with Lidocaine (VYC-17.5L) for lip augmentation in real-world clinical practice. METHODS: This prospective, open-label, multicenter study initially designed for 6 months, then extended to 12 months, enrolled adults with an overall grade of minimal to moderate on the Lip Fullness Scale 2 (LFS2). Optional touch-up and repeat treatments occurred at day 14 and month 12, respectively. The primary endpoint was a ≥1-point improvement on the LFS2 at day 30. Other endpoints included improvements on the FACE-Q Satisfaction with Lips questionnaire, Global Aesthetic Improvement Scale (GAIS), subject assessment of natural look/feel of lips, and investigator assessment of dynamic lip lines upon animation. Injection site reactions (ISRs) and adverse events (AEs) were recorded. RESULTS: Of 60 subjects enrolled (mean age, 36.8 years; 98.3% female), 59 were evaluable for efficacy at day 30; 13 (21.4%) received touch-up treatment. Thirty-six of 40 subjects completed the extension study (month 12). LFS2 responder rates were 93.2% at day 30 (primary endpoint) and 39.0% at month 12. Mean scores on the FACE-Q questionnaire improved from baseline by 45.2 points and 23.6 points at day 30 and month 12, respectively. Most subjects showed improvements on the GAIS. The majority of ISRs were mild/moderate; no serious AEs occurred. CONCLUSIONS: VYC-17.5L was effective and well tolerated for lip augmentation through 12 months posttreatment.