安慰剂
医学
可视模拟标度
不利影响
内科学
外科
随机对照试验
病理
替代医学
作者
Greg Goodman,Lynda Spelman,Nicholas J. Lowe,Blannie E. Bowen
出处
期刊:Dermatologic Surgery
[Ovid Technologies (Wolters Kluwer)]
日期:2021-06-03
卷期号:47 (8): 1065-1070
被引量:3
标识
DOI:10.1097/dss.0000000000003092
摘要
ATX-101 is indicated for submental fat treatment.Evaluate ATX-101 versus placebo for reducing submental fat.Adults with unwanted submental fat across 6 global sites were randomized to ATX-101 (0.5%, 1.0%, or 2.0%) or placebo for ≤4 treatments every 28 days. Outcomes included safety (adverse events and pain visual analog scale) throughout the study and efficacy (submental fat rating, patient satisfaction, and submental fat improvements) at Week 16.Eighty-four of 85 enrolled patients received ≥1 ATX-101 treatment (0.5% [n = 20], 1.0% [n = 20], 2.0% [n = 22] or placebo [n = 22]). Most patients (n = 82) experienced adverse events, which were mostly mild/moderate, seemed to be dose-related, and led to no study discontinuations. The mean pain scores were highest in the ATX-101 1.0% and 2.0% groups. Week-16 change from baseline in the submental fat rating scale was significantly greater for ATX-101 0.5% and 1.0% versus placebo (p ≤ .05). At Week 16, 71%, 74%, 53%, and 40% of patients in the ATX-101 0.5%, 1.0%, 2.0%, and placebo groups, respectively, achieved a ≥1-grade reduction in submental fat from baseline. Satisfaction with appearance and patient-assessed global improvement ratings increased in all ATX-101 treatment groups versus placebo.All ATX-101 concentrations were safe and efficacious for moderate/severe submental fat reduction.
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