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. Objective Evaluate the effectiveness and safety of the HA injectable gel Juvéderm Volift (Allergan, 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.

Real-World Outcomes of Lip Augmentation Using a Hyaluronic Acid-Based Filler With Low 1,4-Butanediol Diglycidyl Ether Content: A Prospective, Open-Label, Multicenter, Post-marketing Study

“…A high responder rate (66.7%) was sustained at the six-month follow-up visit. Interestingly, a previous study evaluating the effectiveness and safety of a traditional HA-based filler (VYC-17.5L) for lip augmentation found that 93.2% of participants were responders at one month; however, this percentage declined significantly to 39% at 12 months [ 8 ]. This suggests that the clinical efficacy of HA fillers crosslinked with reduced amounts of BDDE, as observed in our study, is comparable to commonly used HA fillers in terms of LPS2 increase.…”

“…The primary efficacy endpoint was the post-procedural increase in the investigator-reported LFS2 (0 = minimal, 1 = mild, 2 = moderate, 3 = marked, and 4 = very marked) compared with baseline [ 19 ]. In addition, patients who showed an improvement of at least one point on the LFS2 compared with baseline were considered as responders [ 8 ]. Secondary efficacy endpoints included 1) investigator- and subject-reported Global Aesthetic Improvement Scale (GAIS), rated on a 5-point scale (0 = much worse; 1 = worse; 2 = no change; 3 = improved; 4 = much improved); 2) subject-reported assessment of natural look and feel of lips, rated on a 5-point Likert Scale (0 = not at all to 4 = very much); 3) subject-reported Happiness Measure Scale (HMS), an instrument used to rate subjective well-being on a 11-point Likert Scale (0 = not happy at all to 10 = extremely happy) [ 8 , 18 , 20 ].…”

“…In addition, patients who showed an improvement of at least one point on the LFS2 compared with baseline were considered as responders [ 8 ]. Secondary efficacy endpoints included 1) investigator- and subject-reported Global Aesthetic Improvement Scale (GAIS), rated on a 5-point scale (0 = much worse; 1 = worse; 2 = no change; 3 = improved; 4 = much improved); 2) subject-reported assessment of natural look and feel of lips, rated on a 5-point Likert Scale (0 = not at all to 4 = very much); 3) subject-reported Happiness Measure Scale (HMS), an instrument used to rate subjective well-being on a 11-point Likert Scale (0 = not happy at all to 10 = extremely happy) [ 8 , 18 , 20 ]. Safety endpoints included 1) subject-reported burning, rated on a 5-point Likert Scale (0 = none to 4 = severe), 2) subject-reported pain, rated on a 5-point Likert Scale (0 = none to 4 = severe), 3) investigator-reported edema, rated on a 5-point Likert Scale (0 = none to 4 = severe), and investigator-reported erythema rated on a 5-point Likert Scale (0 = none to 4 = severe).…”

“…To address this gap, a real-world multicenter study was conducted to assess the clinical outcomes of lip augmentation using this filler. We also sought to assess patient-reported outcomes (PROs), a metric gaining recognition for its role in capturing subjective experiences related to aesthetic procedures [ 8 , 17 ]. Specifically, we focused on the influence of the procedure on self-perceived happiness, a significant outcome of interest to patients [ 18 ].…”

Lips enhancement using hyaluronic acid

“…Lip filling with hyaluronic acid is a non-surgical aesthetic procedure that aims to increase lip volume and improve lip contour. 1 Hyaluronic acid is a molecule naturally present in the human body, responsible for maintaining the hydration and elasticity of the skin and connective tissue. Due to its properties, hyaluronic acid has been widely used in aesthetic medicine for facial rejuvenation and volume enhancement in different body areas, including the lips.…”