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.
Male or female subjects who are between 18 to 65 years of age
Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale
Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale
Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug
Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening
Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety
Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period
Parallel
Rcombinant botulinum toxin type A for injection（Eveotox)
Biological/VaccineRcombinant botulinum toxin type A for injection（Eveotox)
OnabotulinumtoxinA (Botox)
Biological/VaccineOnabotulinumtoxinA (Botox)
Placebo
Biological/VaccinePlacebo
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.
Secondary Outcome Measure
Incidence of serious adverse events and drug-related adverse events during the study.
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