Actively Recruiting
Phase 3 Study to Evaluate Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) Compared With Botox and Placebo for Moderate to Severe Glabellar Lines with Repeated Eveotox Treatment
Led by JHM BioPharma (Tonghua) Co. , Ltd. · Updated on 2025-09-02
669
Participants Needed
15
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and immune response of Eveotox, a recombinant botulinum toxin type A, for treating moderate to severe glabellar lines. This Phase 3 study includes two parts: Part 1 is a randomized, double-blind, controlled trial comparing Eveotox with Botox and placebo; Part 2 is an open-label study assessing repeated Eveotox injections. The study aims to understand how well Eveotox works and its safety profile in this population. Participants receive one of three treatments during the first cycle: Eveotox (20 Units divided into five injections), Botox (20 Units), or placebo, all administered into the glabellar area in a double-blind fashion. After the initial cycle, participants may receive up to three additional open-label cycles of Eveotox. This dosing and schedule allows comparison of single and repeated treatments. During the study, participants will attend scheduled visits for assessments of wrinkle severity using investigator and patient scales, safety checks, and monitoring of immune response. The primary outcome is measured within 4 weeks, with secondary outcomes evaluated up to 52 weeks. Participants must be willing and able to follow study procedures throughout the trial, which runs until August 2026.
CONDITIONS
Brief Title
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 to 65 years
- Moderate or severe glabellar lines during maximum frown based on Investigator Global Assessment
- Moderate or severe glabellar lines during maximum frown based on Patient Frown Wrinkle Severity scale
- Willing and able to follow all trial procedures, attend scheduled visits, and complete the trial
You will not qualify if you...
- History of oversensitivity to Botulinum Toxin A or components of the study drug
- Implanted permanent materials in glabellar area or semi-permanent fillers within 2 years before screening
- Active skin infections at the injection site or systemic skin disease affecting safety or efficacy evaluation
- History of injecting drugs similar to study drug within 6 months prior to selection or planned use during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive injections of either Eveotox, Botox, or placebo during the first cycle, followed by up to three open-label cycles of Eveotox.
Up to 4 treatment visits
Trial Site Locations
Total: 15 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Actively Recruiting
6
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
7
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
8
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
9
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
10
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
11
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
Actively Recruiting
12
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
13
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
14
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
Actively Recruiting
15
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
D
Danhua Lin
L
Lei Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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