title: Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study.
abstract: BACKGROUND
  Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement.
  
  
  OBJECTIVE
  Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®).
  
  
  METHODS
  This 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.
  
  
  RESULTS
  Juvéderm 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.
  
  
  CONCLUSIONS
  Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.
authors.forename: Hervé
authors.initials: H
authors.lastname: Raspaldo
authors.forename: Jonquille
authors.initials: J
authors.lastname: Chantrey
authors.forename: Lakhdar
authors.initials: L
authors.lastname: Belhaouari
authors.forename: David
authors.initials: D
authors.lastname: Eccleston
authors.forename: Roy
authors.initials: R
authors.lastname: Saleh
authors.forename: Raj
authors.initials: R
authors.lastname: Acquilla
authors.forename: Diane K
authors.initials: DK
authors.lastname: Murphy
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003357:Cosmetic Techniques; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008012:Lidocaine / Q000009:adverse effects / Q000627:therapeutic use*; D008046:Lip / Q000033:anatomy & histology* / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009055:Mouth / Q000033:anatomy & histology* / Q000187:drug effects*; D011446:Prospective Studies; D012060:Rejuvenation; D012867:Skin / Q000033:anatomy & histology / Q000187:drug effects; D055815:Young Adult
chemical_list: D006820:Hyaluronic Acid; D008012:Lidocaine; C445361:Restylane