This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China
Shanghai Ninth People's Hospital,Shanghai JiaoTong University school of Medicine
Shanghai, Shanghai Municipality, China
Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection
Time frame: Within 28 days
Phase1:The incidence rate of injection site reaction within 28 days after injection
Time frame: Within 28 days
Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection
Time frame: Within 28 days
Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown
A response rate is defined as a subject who achieves a score of 0 or 1 in GL severity at maximum frown and at least 2 grades improvement from baseline by investigator's assessment
Time frame: 28 days
Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection
Time frame: within 12 weeks
Phase2:The incidence rate of injection site reaction within 12 weeks after injection
Time frame: within 12 weeks
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West China Hospital,Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China