title: A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides.
abstract: OBJECTIVE
  To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine (SPHAL) versus no treatment for lip augmentation and perioral rhytides.
  
  
  METHODS
  Adults scoring 1 (very thin) to 2 (thin) on the Medicis Lip Fullness Scale (MLFS) for upper and lower lips were randomized (3:1) to SPHAL or no treatment. Treatment success was an MLFS increase ≥1 point at Week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale, Wrinkle Assessment Scale for Upper Lip Lines) and safety were assessed throughout.
  
  
  RESULTS
  Statistically significantly more patients were treatment successes with SPHAL (upper lip [80.2% vs 11.9%], lower lip [84.2% vs 18.4%], and upper and lower lips combined [76.1% vs 11.6%]), compared with no treatment (p <.001, all outcomes). Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides (p <.001). Most common treatment-emergent adverse events (AEs) included lip bruising, swelling, and pain and were mostly mild and transient in nature, without anticipated device AEs.
  
  
  CONCLUSIONS
  Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated, with improvement evident up to 6 months after treatment.
authors.affiliation: *Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania; †Department of Dermatology, University of California, San Francisco, California; ‡Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; §Department of Dermatology, Geffen School of Medicine, University of California Los Angeles, Los Angeles, California; ‖Valeant Aesthetics, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey; ¶Inergy Limited, Lindfield, United Kingdom.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Beer
authors.forename: Richard G
authors.initials: RG
authors.lastname: Glogau
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Dover
authors.forename: Ava
authors.initials: A
authors.lastname: Shamban
authors.forename: Lata
authors.initials: L
authors.lastname: Handiwala
authors.forename: Jason T
authors.initials: JT
authors.lastname: Olin
authors.forename: Brian
authors.initials: B
authors.lastname: Bulley
mesh_terms: D000293:Adolescent; D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D003288:Contusions / Q000139:chemically induced; D003357:Cosmetic Techniques; D004487:Edema / Q000139:chemically induced; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007271:Injections, Intradermal; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008046:Lip; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D010316:Particle Size; D012060:Rejuvenation; D015595:Skin Aging; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D005782:Gels; D006820:Hyaluronic Acid; D008012:Lidocaine