[Translation] A multicenter, randomized, double-blind, non-inferiority, active-drug parallel-controlled Phase III clinical trial to evaluate the efficacy and safety of JTM201 injection versus Botox® for improving moderate to severe glabellar lines in Chinese subjects
主要研究目的:评价试验药物 JTM201 注射液用于改善中度至重度眉间纹的有效性,以证实 JTM201 注射液对
于眉间纹的改善效果非劣于保妥适®。
次要研究目的:(1)评价 JTM201 注射液用于改善中度至重度眉间纹的安全性。(2)评价 JTM201 注射液多
次注射用于改善中度至重度眉间纹的有效性和安全性(仅适用于第二阶段试验)。
[Translation] Primary study objectives: To evaluate the effectiveness of the experimental drug JTM201 injection in improving moderate to severe glabellar lines, and to confirm that JTM201 injection is non-inferior to Botox® in improving glabellar lines.
Secondary study objectives: (1) To evaluate the safety of JTM201 injection in improving moderate to severe glabellar lines. (2) To evaluate the effectiveness and safety of multiple injections of JTM201 injection in improving moderate to severe glabellar lines (only applicable to Phase II trials).