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Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

RecruitingPhase 3Ages 18 Years - 65 YearsAllJHM BioPharma (Tonghua) Co. , Ltd.
NCT06937944 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Rcombinant botulinum toxin type A for injection（Eveotox)
  • OnabotulinumtoxinA (Botox)
  • Placebo
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Where

15 sites
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Jinan University
Guangzhou, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
The Third Xiangya Hospital of Central South University
Changsha, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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