This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
669
Rcombinant botulinum toxin type A for injection(Eveotox)
OnabotulinumtoxinA (Botox)
Placebo
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
RECRUITINGThe Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGHuashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING...and 5 more locations
Primary Outcome Measure
Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments.
Time frame: Within 4 weeks
Secondary Outcome Measure
Incidence of serious adverse events and drug-related adverse events during the study.
Time frame: Within 52 weeks
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