• Dermatol Surg · Dec 2015

    Randomized Controlled Trial Multicenter Study

    HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial.

    • Kimberly Butterwick, Ellen Marmur, Vic Narurkar, Sue Ellen Cox, John H Joseph, Neil S Sadick, Ruth Tedaldi, Sarah Wheeler, Julia K Kolodziejczyk, and Conor J Gallagher.
    • *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.
    • Dermatol Surg. 2015 Dec 1; 41 (12): 1351-60.

    ObjectiveThis 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.Materials And MethodsMen 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.ResultsA 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.ConclusionHYC-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.

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