title: Functional safety assessments used in a randomized controlled study of small gel particle hyaluronic acid for lip augmentation.
abstract: BACKGROUND
  Dermal fillers are commonly injected in the lips for aesthetic treatment. Small gel particle hyaluronic acid (SGP-HA) is the only filler approved by the US Food and Drug Administration for this indication, based on a pivotal trial of effectiveness and safety.
  
  
  OBJECTIVE
  To assess multiple measures of tolerability and lip function in a randomized controlled trial of SGP-HA (without lidocaine) for lip augmentation.
  
  
  METHODS
  Patients were randomized to SGP-HA (n = 135) or no treatment (n = 45) at baseline; all could receive SGP-HA after 6 months. Assessments for tolerability and lip function at clinic visits throughout the study included lip texture, firmness, symmetry, movement, function, and sensation; device palpability; mass formation; and ease of repeat injection.
  
  
  RESULTS
  Many assessments were normal (lip function, sensation) or unremarkable (movement, mass formation, ease of reinjection) in most patients. Nearly all abnormalities with other assessments (texture, firmness, symmetry, device palpability) were mild and transient (<4 weeks).
  
  
  CONCLUSIONS
  Lip augmentation with SGP-HA showed excellent safety with the assessments used in this study. Further study should be conducted to validate these assessments with the goal of developing a comprehensive scale for measuring potential functional complications and risks.
authors.affiliation: *Private Practice, Encinitas, California; †Valeant Dermatology, Division of Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey; ‡Complete Healthcare Communications, Inc., Chadds Ford, Pennsylvania; §Ancor Pharmaceuticals Inc., Palo Alto, California.
authors.forename: Stacy R
authors.initials: SR
authors.lastname: Smith
authors.forename: Heather M
authors.initials: HM
authors.lastname: Vander Ploeg
authors.forename: Mary
authors.initials: M
authors.lastname: Sanstead
authors.forename: Craig D
authors.initials: CD
authors.lastname: Albright
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Theisen
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Lin
mesh_terms: D003357:Cosmetic Techniques; D004954:Esthetics; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects*; D007271:Injections, Intradermal; D008046:Lip / Q000033:anatomy & histology / Q000502:physiology; D009068:Movement; D010316:Particle Size; D011446:Prospective Studies; D012060:Rejuvenation; D012677:Sensation; D015595:Skin Aging
chemical_list: D005782:Gels; D006820:Hyaluronic Acid