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:Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler.Methods:In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated treatment outcomes on Allergan’s Lip Fullness Scale, Perioral Lines Scale, and Oral Commissures Severity Scale. A blinded independent central reviewer (ICR) assessed 3-dimensional digital photographs using these scales. Subjects evaluated outcomes using the FACE-Q Recovery Early Life Impact and Recovery Early Symptoms modules. The primary endpoint was noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L based on responder rate (percentage of subjects with ≥1-point Lip Fullness Scale improvement at month 3 ICR assessment vs baseline).Results:Juvéderm Volbella with Lidocaine was noninferior to Restylane-L. Although responder rates based on ICR assessments of lip fullness, perioral lines, and oral commissures did not differ between treatments, investigator assessments showed significant improvements in perioral lines and oral commissures with Juvéderm Volbella with Lidocaine vs Restylane-L (P ≤ 0.029). Subjects treated with Juvéderm Volbella with Lidocaine had higher mean FACE-Q scores on day 1 (P ≤ 0.001), indicating less disruption of daily activities. Mean change in lip volume from baseline to day 1 was smaller in the Juvéderm Volbella with Lidocaine group (but similar between treatments on day 14), indicating less acute swelling. Severe injection site responses occurred less frequently with Juvéderm Volbella with Lidocaine.Conclusions:Juvéderm Volbella with Lidocaine is effective for lip enhancement, improves perioral lines and oral commissures, and results in less short-term swelling and disruption in daily activities than Restylane-L.
Background: Factors that motivate the treatment goals and expectations of the aesthetic patient reflect evolving social, cultural, and commercial influences. The aesthetic practitioner may often be faced with the challenge of first decoding the underlying motives that drive the patient to pursue their specific goals. The challenge for clinicians is further compounded by an increase in patient diversity with respect to race, ethnicity, age, and gender.Aims: Simplify the path to patient interpretation with identification of primary patient archetypes. Methods:The "Going Beyond Beauty" (GBB) initiative, consisting of 27 market research projects, was conducted to survey the primary goals and motives for seeking treatment aesthetic treatment. The results were stratified into predominant patient archetypes using segmentation analysis and then validated through online surveys, 1-to-1 interviews, and focus groups conducted with patients. An advisory board of internationally based aesthetic clinicians integrated the data with their own insights to further characterize each archetype.Results: Data from over 54 000 participants in 17 different countries were distilled into four distinct patient archetypes based on motivating factors, aesthetic goals, initial treatment requests, and treatment opportunities and challenges. These archetypes were named Beautification, Positive Aging, Transformation, and Correction. Conclusion:The clinician's ability to recognize these four primary archetypes may provide a useful frame of reference to understand patient motives better, anticipate and manage their expectations, and provide the appropriate treatment guidance that best serves the long-term goals of their patients.
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