Department of General Practice, Monash University, Clayton, VIC, Australia.
University College of London, London, United Kingdom.
Dermatol Surg. 2021 Aug 1;47(8):1065-1070. doi: 10.1097/DSS.0000000000003092.
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.
ATX-101 用于治疗下颌脂肪。
评估 ATX-101 与安慰剂在减少下颌脂肪方面的效果。
6 个全球地点的不想要下颌脂肪的成年人被随机分配到 ATX-101（0.5%、1.0%或 2.0%）或安慰剂组，每 28 天接受最多 4 次治疗。结果包括整个研究过程中的安全性（不良事件和疼痛视觉模拟量表）和第 16 周的疗效（下颌脂肪评分、患者满意度和下颌脂肪改善）。
85 名入组患者中，84 名患者至少接受了 1 次 ATX-101 治疗（0.5%[n=20]、1.0%[n=20]、2.0%[n=22]或安慰剂[n=22]）。大多数患者（n=82）出现不良事件，大多为轻度/中度，似乎与剂量有关，且无研究中止。ATX-101 1.0%和 2.0%组的平均疼痛评分最高。与安慰剂相比，ATX-101 0.5%和 1.0%组在第 16 周时下颌脂肪评分量表的基线变化显著更大（p≤0.05）。第 16 周时，ATX-101 0.5%、1.0%、2.0%和安慰剂组的患者中，分别有 71%、74%、53%和 40%达到了从基线起至少减少 1 级的下颌脂肪改善。所有 ATX-101 治疗组的患者对外观的满意度和患者评估的整体改善评分均高于安慰剂组。
所有 ATX-101 浓度对中度/重度下颌脂肪减少均安全有效。
