title: HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial.
abstract: OBJECTIVE
  This trial compares the effectiveness and safety of HYC-24L (Juvéderm Ultra XC; Allergan plc, Dublin, Ireland) (24 mg/mL of hyaluronic acid, 0.3% lidocaine) and CPM-22.5 (Belotero Balance; Merz Aesthetics, Raleigh, NC) (22.5 mg/mL of hyaluronic acid) for the treatment of perioral lines.
  
  
  METHODS
  Men and women aged 35 years or older with moderate-to-severe perioral lines were recruited for this randomized controlled, rater-blinded, 2-arm trial. The primary endpoint was a comparison of rater-assessed responder rates by the validated 4-point Perioral Lines Severity Scale at Month 6; responders were those who showed a ≥1 point improvement. A secondary endpoint was subject-assessed change in perioral lines measured by the Global Assessment of Change Scale.
  
  
  RESULTS
  A total of 136 subjects received treatment and 132 completed the trial (mean age: 58 ± 8 years). Total volume injected was 1.18 mL (HYC-24L) and 1.32 mL (CPM-22.5). At Month 6, a significantly greater proportion of HYC-24L subjects responded to treatment (87%) than CPM-22.5 subjects (72%) (p < .04). At all time points, HYC-24L subjects reported significantly greater improvement in their perioral lines than CPM-22.5 subjects, with the greatest difference at Month 6. No unexpected adverse events occurred.
  
  
  CONCLUSIONS
  HYC-24L subjects showed a higher response rate and a greater improvement in their perioral lines than CPM-22.5 subjects for up to 6 months.
authors.affiliation: *Private Practice, San Diego, California; †Marmur Medical, New York, New York; ‡Bay Area Laser Institute, San Francisco, California; §Aesthetic Solutions, Chapel Hill, North Carolina; ‖Private Practice, Beverly Hills, California; ¶Sadick Dermatology, New York, New York; #Dermatology Partners, Inc., Wellesley, Massachusetts; **Allergan plc, Irvine, California.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Butterwick
authors.forename: Ellen
authors.initials: E
authors.lastname: Marmur
authors.forename: Vic
authors.initials: V
authors.lastname: Narurkar
authors.forename: Sue Ellen
authors.initials: SE
authors.lastname: Cox
authors.forename: John H
authors.initials: JH
authors.lastname: Joseph
authors.forename: Neil S
authors.initials: NS
authors.lastname: Sadick
authors.forename: Ruth
authors.initials: R
authors.lastname: Tedaldi
authors.forename: Sarah
authors.initials: S
authors.lastname: Wheeler
authors.forename: Julia K
authors.initials: JK
authors.lastname: Kolodziejczyk
authors.forename: Conor J
authors.initials: CJ
authors.lastname: Gallagher
mesh_terms: D003288:Contusions / Q000209:etiology; D003357:Cosmetic Techniques / Q000009:adverse effects; D000067548:Dermal Fillers / Q000008:administration & dosage* / Q000009:adverse effects; D004954:Esthetics; D005145:Face; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007279:Injections, Subcutaneous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D015595:Skin Aging / Q000187:drug effects*
chemical_list: D000067548:Dermal Fillers; C526061:Juvederm Ultra; C584568:belotero balance; D006820:Hyaluronic Acid