[Translation] A randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of oral sarecycline at approximately 1.5 mg/kg/day for 12 weeks in patients with moderate to severe acne vulgaris
主要目的:本试验的主要目的是根据炎性病灶计数,评价口服Sarecycline 与安慰剂相比治疗中重度寻常性痤疮患者的疗效。
次要目的:是根据不良事件、生命体征、体格检查和临床实验室检查来评价口服Sarecycline的安全性。
[Translation] Primary objective: The primary objective of this trial was to evaluate the efficacy of oral sarecycline compared with placebo in patients with moderate to severe acne vulgaris, based on inflammatory lesion count.
Secondary objective: To evaluate the safety of oral sarecycline based on adverse events, vital signs, physical examination, and clinical laboratory tests.