title: A randomized, evaluator-blinded, controlled study of the effectiveness and safety of small gel particle hyaluronic acid for lip augmentation.
abstract: OBJECTIVE
  To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation.
  
  
  METHODS
  Adults (n = 180; aged 18-65) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA (≤1.5 mL/lip) or no treatment. Co-primary effectiveness end points were blinded-evaluator MLFS score for upper or lower lip at week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale [GAIS], safety assessments) were measured throughout the study.
  
  
  RESULTS
  Statistically significantly more MLFS responders (≥1 grades of MLFS improvement at week 8) received SGP-HA (93% combined upper and lower lip responders [95% upper lip; 94% lower lip]) than no treatment (29% combined; p < .001). SGP-HA improved self-assessed combined lip GAIS (97% week 8; 74% week 24) significantly more than no treatment (0% throughout; p < .001). The SGP-HA group reported anticipated swelling (58%) and bruising (44%), 88% mild or 11% moderate severity, without unanticipated device adverse events.
  
  
  CONCLUSIONS
  SGP-HA is highly effective and well tolerated for lip augmentation. Statistically significant improvement was evident based on the MLFS at 8 weeks, with visible results reported in the majority of participants 6 months after treatment.
authors: San Francisco Dermatology, 350 Parnassus Ave, Suite 400, San Francisco, CA 94117, USA. rglogau@aol.com
authors: Richard G
authors: RG
authors: Glogau
authors: David
authors: D
authors: Bank
authors: Fredric
authors: F
authors: Brandt
authors: Sue Ellen
authors: SE
authors: Cox
authors: Lisa
authors: L
authors: Donofrio
authors: Jeffrey
authors: J
authors: Dover
authors: Steven
authors: S
authors: Grekin
authors: Ira
authors: I
authors: Lawrence
authors: Xiaoming
authors: X
authors: Lin
authors: Mark
authors: M
authors: Nestor
authors: Ava
authors: A
authors: Shamban
authors: Daniel
authors: D
authors: Stewart
authors: Robert
authors: R
authors: Weiss
authors: Robert A
authors: RA
authors: Axford-Gatley
authors: Michael J
authors: MJ
authors: Theisen
authors: Stacy
authors: S
authors: Smith
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008046:Lip / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D006820:Hyaluronic Acid