[Translation] A Phase III clinical study evaluating the efficacy and safety of injectable botulinum toxin type A (CU-20101) compared with BOTOX® single treatment and repeated treatment of CU-20101 in the treatment of moderate to severe glabellar lines
主要目的:以保妥适®为阳性对照,评价CU-20101单次注射治疗中重度眉间纹的有效性。
次要目的:以保妥适®为阳性对照,评价CU-20101单次注射治疗中重度眉间纹的安全性及免疫原性。评价CU-20101重复注射治疗中重度眉间纹的安全性、有效性和免疫原性。
[Translation] Primary objective: To evaluate the efficacy of a single injection of CU-20101 in the treatment of moderate to severe glabellar lines, using Botox® as a positive control.
Secondary objective: To evaluate the safety and immunogenicity of a single injection of CU-20101 in the treatment of moderate to severe glabellar lines, using Botox® as a positive control. To evaluate the safety, efficacy and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.