Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Modera… (NCT06937944) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
China669 participantsStarted 2025-04-30
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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