title: An open-label, pilot study to assess the effectiveness and safety of hyaluronic acid gel in the restoration of soft tissue fullness of the lips.
abstract: BACKGROUND
  There have been few systematic investigations of the effectiveness, safety and tolerability of aesthetic lip augmentation using hyaluronic acid (HA) fillers.
  
  
  OBJECTIVE
  Evaluate the effectiveness of small gel particle hyaluronic acid filler (Restylane Injectable Gel [SGP-HA]; Medicis Aesthetics Inc., Scottsdale, AZ) in lip augmentation using the Medicis Lip Fullness Scale (MLFS). Assess subjective improvement in lip appearance using the Global Aesthetic Improvement Scale (GAIS).
  
  
  METHODS
  Investigators treated 21 adults. The primary efficacy endpoint was an increase in lip fullness at least one grade on MLFS at eight weeks post-treatment. Adverse events were reported using patient diaries.
  
  
  RESULTS
  Sixteen of 18 evaluable subjects (89%) had an improvement at least one grade on MLFS in both lips. MLFS and GAIS scores were consistent, suggesting clinically significant aesthetic improvement. Adverse effects were transient and mostly mild to moderate in severity.
  
  
  CONCLUSIONS
  Lip augmentation with SGP-HA was well tolerated and resulted in clinically meaningful increases in lip fullness.
authors.affiliation: The University of Toronto, Toronto, Ontario, Canada. n.solish@utoronto.ca
authors.forename: Nowell
authors.initials: N
authors.lastname: Solish
authors.forename: Arthur
authors.initials: A
authors.lastname: Swift
mesh_terms: D000328:Adult; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives*; D007267:Injections; D008046:Lip; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012060:Rejuvenation; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D005782:Gels; D006820:Hyaluronic Acid; C445361:Restylane