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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.
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.
Official title: A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection (Eveotox) Compared With a Single Treatment of Botox and Placebo,and Repeated Treatment of Eveotox in Moderate to Severe Glabellar Lines
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
669
Start Date
2025-04-30
Completion Date
2026-08
Last Updated
2025-09-02
Healthy Volunteers
No
Conditions
Interventions
Rcombinant botulinum toxin type A for injection(Eveotox)
Rcombinant botulinum toxin type A for injection(Eveotox)
OnabotulinumtoxinA (Botox)
OnabotulinumtoxinA (Botox)
Placebo
Placebo
Locations (15)
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