title: Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation.
abstract: BACKGROUND
  Hyaluronic acid gels are increasingly used for augmentation of the lips.
  
  
  OBJECTIVE
  To assess the safety and effectiveness of Juvéderm Ultra XC, a 24 mg/mL hyaluronic acid gel containing 0.3% (wt/wt) lidocaine (HYC-24L), for augmentation of the lips.
  
  
  METHODS
  This ongoing, multicenter, single-blind study randomized 213 subjects to the treatment group (n = 157) or concurrent no-treatment control group that received delayed treatment (n = 56). The primary effectiveness endpoint was the responder rate (≥1 point improvement from baseline) based on the blinded evaluating investigator's assessment of the subject's overall lip fullness (or fullness of the eligible lip) using the validated Allergan 5-point Lip Fullness Scale. To meet this endpoint, the treatment group had to have a responder rate ≥60% and significantly greater than the treatment control group at Month 3.
  
  
  RESULTS
  The primary endpoint was met, with a 79.1% responder rate for the treatment group and 26.1% for the treatment control group (p < 0.0001). More than half of subjects (56.4%) maintained treatment response for 12 months. Common injection site responses were swelling, bruising, and firmness; most were of mild or moderate severity.
  
  
  CONCLUSIONS
  HYC-24L is safe and effective for aesthetic lip augmentation, with results lasting up to 1 year.
authors.affiliation: *DeNova Research, Chicago, Illinois; †Suzanne Bruce and Associates, PA, Houston, Texas; ‡Laser & Skin Surgery Center of Northern California, Sacramento, California; §SkinCare Physicians, Chestnut Hill, Massachusetts; ‖Image Dermatology, Montclair, New Jersey; ¶Society Hill Dermatology, Philadelphia, Pennsylvania; #Peloton Advantage, LLC, Parsippany, New Jersey; **Allergan plc, Irvine, California.
authors.forename: Steven
authors.initials: S
authors.lastname: Dayan
authors.forename: Suzanne
authors.initials: S
authors.lastname: Bruce
authors.forename: Suzanne
authors.initials: S
authors.lastname: Kilmer
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Dover
authors.forename: Jeanine B
authors.initials: JB
authors.lastname: Downie
authors.forename: Susan C
authors.initials: SC
authors.lastname: Taylor
authors.forename: Annette
authors.initials: A
authors.lastname: Skorupa
authors.forename: Diane K
authors.initials: DK
authors.lastname: Murphy
mesh_terms: D000328:Adult; D000368:Aged; D003357:Cosmetic Techniques; D000067548:Dermal Fillers / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007271:Injections, Intradermal; D008046:Lip; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D012060:Rejuvenation; D016037:Single-Blind Method; D015595:Skin Aging / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000067548:Dermal Fillers; C526061:Juvederm Ultra; D006820:Hyaluronic Acid