title: Effectiveness and Safety of Large Gel Particle Hyaluronic Acid With Lidocaine for Correction of Midface Volume Deficit or Contour Deficiency.
abstract: BACKGROUND
  Aging effects, such as facial flatness, increased tissue laxity, and soft tissue descent and deflation, contribute to midface deficiency.
  
  
  OBJECTIVE
  To evaluate whether large gel particle hyaluronic acid with lidocaine (LGP-HAL) is more effective in the treatment of midface deficiencies than no treatment.
  
  
  METHODS
  Subjects with mild to substantial loss of midface fullness were randomized 3:1 to LGP-HAL (Restylane Lyft; Galderma Laboratories, L.P., Fort Worth, TX) or no treatment. Treatment success was defined as at least 1-grade improvement in Medicis Midface Volume Scale (MMVS) on each side of the face at 8 weeks as assessed by a blinded evaluator. Secondary efficacy end points included MMVS score, global aesthetic improvement, and subject satisfaction.
  
  
  RESULTS
  Significantly greater percent of subjects achieved treatment success in the LGP-HAL group compared to no treatment at all time points through Month 12 (p < .001). One year after initial treatment, 85% of subjects still had a global aesthetic improvement assessed by the treating investigator. Subject satisfaction demonstrated that LGP-HAL improved the aesthetic appearance of the midface. Most reported adverse events (80%) were mild in severity.
  
  
  CONCLUSIONS
  The LGP-HAL treatment is well tolerated and provides significant improvement up to 12 months for the correction of midface deficiencies.
authors.affiliation: *Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland; †Private Practice, Vista, California; ‡The Center for Dermatology, Cosmetic & Laser Surgery, Mount Kisco, New York; §Private Practice, Chicago, Illinois; ‖Private Practice and Director of the Clinical Testing Center of Beverly Hills, Beverly Hills, California; ¶SkinCare Physicians, Chestnut Hill, Massachusetts; #Galderma R&D, Uppsala, Sweden; **Galderma Laboratories, L.P., Fort Worth, Texas.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Weiss
authors.forename: Amir
authors.initials: A
authors.lastname: Moradi
authors.forename: David
authors.initials: D
authors.lastname: Bank
authors.forename: Julius
authors.initials: J
authors.lastname: Few
authors.forename: John
authors.initials: J
authors.lastname: Joseph
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Dover
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Lin
authors.forename: Alessandra
authors.initials: A
authors.lastname: Nogueira
authors.forename: Jay
authors.initials: J
authors.lastname: Mashburn
mesh_terms: D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D003357:Cosmetic Techniques / Q000009:adverse effects; D004954:Esthetics; D005145:Face; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D017060:Patient Satisfaction; D016037:Single-Blind Method; D015595:Skin Aging; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States; D055675:Viscosupplements / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000779:Anesthetics, Local; D005782:Gels; D055675:Viscosupplements; D006820:Hyaluronic Acid; D008012:Lidocaine