• Hervé Raspaldo, Jonquille Chantrey, Lakhdar Belhaouari, David Eccleston, Roy Saleh, Raj Acquilla, and Diane K Murphy.
• J Drugs Dermatol. 2015 Dec 1; 14 (12): 1444-52.

BackgroundJuvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement.ObjectiveEvaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®).MethodsThis study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan's Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥ 1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment.ResultsJuvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P ≤ .03), perioral lines (P ≤ .04), and oral commissures (P ≤ .03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler.ConclusionsJuvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.

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