This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
190
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site.
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Phase1
The incidence rate of adverse events and severe adverse events within 28 days after injection;
Time frame: Within 28 days
Phase2
Percentage of Subjects as Responders in the Investigator's live assessment (Using 4-point Photographic Scale) and the subject's self assessment of Glabellar Lines at Maximum Frown.
Time frame: within 4 weeks
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