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

2015; Lippincott Williams & Wilkins; Volume: 41; Issue: 12 Linguagem: Inglês

10.1097/dss.0000000000000576

1524-4725

Kimberly J. Butterwick, Ellen S. Marmur, Vic A. Narurkar, Sue Ellen Cox, John Joseph, Neil S. Sadick, Ruth Tedaldi, Sarah Wheeler, Julia K. Kolodziejczyk, Conor J. Gallagher,

Glaucoma and retinal disorders

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.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.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.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.