PMID- 35795884 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230214 IS - 2631-4797 (Electronic) IS - 2631-4797 (Linking) VI - 4 DP - 2022 TI - A Prospective, Open-Label, Multicenter, Real-World Study of VYC-17.5L Hyaluronic Acid Dermal Filler in the Lips. PG - ojac047 LID - 10.1093/asjof/ojac047 [doi] LID - ojac047 AB - 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 Juvederm 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. CI - (c) 2022 The Aesthetic Society. FAU - Demosthenous, Nestor AU - Demosthenous N FAU - Eccleston, David AU - Eccleston D FAU - Figueiredo, Vitor AU - Figueiredo V FAU - Uva, Luis AU - Uva L FAU - Kerson, Graeme AU - Kerson G FAU - Silberberg, Michael AU - Silberberg M LA - eng PT - Journal Article DEP - 20220515 PL - England TA - Aesthet Surg J Open Forum JT - Aesthetic surgery journal. Open forum JID - 101771713 PMC - PMC9252021 EDAT- 2022/07/08 06:00 MHDA- 2022/07/08 06:01 PMCR- 2022/05/15 CRDT- 2022/07/07 02:39 PHST- 2022/07/07 02:39 [entrez] PHST- 2022/07/08 06:00 [pubmed] PHST- 2022/07/08 06:01 [medline] PHST- 2022/05/15 00:00 [pmc-release] AID - ojac047 [pii] AID - 10.1093/asjof/ojac047 [doi] PST - epublish SO - Aesthet Surg J Open Forum. 2022 May 15;4:ojac047. doi: 10.1093/asjof/ojac047. eCollection 2022.