RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: JHM BioPharma (Tonghua) Co. , Ltd. • ClinicalTrials.gov ID: NCT06937944

Registry updated: 2026-09-23

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Description

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.

Interventions

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

Eligibility criteria

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

Conditions

Moderate to Severe Glabellar Lines

Locations

Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
Peking University First Hospital — Beijing, Beijing Municipality, China
Peking University Third Hospital — Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
Xianyang Hospital of Yan'an University — Xianyang, Shanxi, China
West China Hospital, Sichuan University — Chengdu, Sichuan, China
Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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