一项评价注射用A型肉毒毒素(CU-20101)对比保妥适®单次治疗以及CU-20101重复治疗中重度眉间纹的有效性和安全性的III期临床研究
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。
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101) Compared With A Single Treatment of Botox ® and Repeated Treatment of CU-20101 in Moderate to Severe Glabellar Striae
This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines. The study consisted of a 7-day screening period, Study Part 1 (randomized double-blind controlled study) and Period 2 (open-label study). Part I was a multicenter, randomized, double-blind, single-injection, active-drug parallel-controlled, non-inferiority design clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox®; part 2 was an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.
100 项与 CU-20101 相关的专利(医药)