ObjectiveEvaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection.Materials and methodsIn a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed.ResultsOf 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate.ConclusionVYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.
BACKGROUND Millennials (aged 18–34 years) represent a growing segment of the facial aesthetic market. OBJECTIVE To evaluate investigator-assessed efficacy, patient-reported outcomes (PROs), and safety for millennials versus subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies. METHODS Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or placebo. All findings were pooled by the age group. RESULTS Millennials composed 15% of subjects (176/1,178). Day 30 responder rates of at least 1-grade Facial Wrinkle Scale improvement in FHL severity for millennials versus subjects aged 35 years and older were 100% versus 97.8% at maximum eyebrow elevation and 78.4% versus 83.5% at rest, respectively. Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180. Similar trends were observed for achieving none/mild severity. Both age groups reported high satisfaction rates and improved psychological impacts with onabotulinumtoxinA treatment. No new safety signals were detected. CONCLUSION OnabotulinumtoxinA treatment was well tolerated, and both age groups experienced significant improvements in FHL severity, high satisfaction, and improved psychological impacts after treatment. Millennials reported numerically greater improvements.
VYC-15L is effective and safe for the treatment of infraorbital depressions, with effectiveness lasting up to 12 months.
Background: VYC-12, a hyaluronic acid injectable gel, is designed to treat fine lines and provides improvements in other skin quality attributes. A prospective study demonstrated the safety and effectiveness of VYC-12 for the improvement of fine lines as measured by changes in skin texture. Aims:To evaluate patient-reported outcomes in subjects treated intradermally with VYC-12 in the cheeks, forehead, and neck (optional) in the prospective study.Methods: Subjects received an initial treatment of VYC-12 (N = 131), with a touch-up treatment, if deemed necessary, offered 30 days later, and optional repeat treatment 9 months after initial or touch-up treatment. Subjects completed the FACE-Q Satisfaction With Skin scale and assessed willingness to recommend treatment to a friend at baseline, months 1, 4, 6, and 9, and month 1 after repeat treatment. Subjects also evaluated their return to normal daily social activities.Results: Satisfaction with skin improved from baseline in 90.8% of subjects at month 1, 88.4% at month 4, 83.6% at month 6, 76.4% at month 9, and 91.9% at month 1 after repeat treatment (P < .001, all time points). At least 94% of subjects returned to normal daily social activities one day after treatment (initial, touch-up, or repeat).More than 80% of subjects said they would recommend treatment to a friend at all time points through month 9 (97% at month 1 after repeat treatment). Conclusion:Treatment with VYC-12 significantly improved satisfaction with skin in the majority of subjects, with most subjects returning to normal activities 1 day after treatment. K E Y W O R D Saesthetics, dermal fillers, hyaluronic acid, patient-reported outcome measures, skin aging
Background: VYC-12L is a hyaluronic acid (HA) injectable gel designed to treat fine cutaneous lines and improve skin quality attributes such as hydration and elasticity. Objective: Expert consensus was sought on VYC-12L injection technique and primary treatment target areas. Methods: A multinational group of aesthetic medicine clinicians (n = 128) attended product training and each identified~10 patients for VYC-12L. After treating their first and last patients, the clinicians completed a survey on preferred injection methodology/technique, including injection angle, volume, and spacing. An expert panel (n = 12) discussed survey results and their clinical experiences to obtain consensus on VYC-12L technique and appropriate treatment areas. Results: Recommendations included micro-depot injections of VYC-12L into the deep dermis with a 32G ½ inch needle inserted at <45º to the skin, spaced 0.5-1.0 cm apart, with 0.01-0.05 mL volume per injection (full-face total volume:~2 mL). Recommended primary treatment areas were the malar, perioral, neck, and décolletage regions. Injection techniques for different treatment areas/demographic characteristics were similar, with some variability in treatment approach. Patient selection criteria, pre-and post-treatment guidelines, and managing patient expectations are important components of treatment. Conclusion: These consensus recommendations may assist clinicians in optimizing the treatment of fine lines with VYC-12L.
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