Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
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
1 other identifier
interventional
669
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2025
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedSeptember 2, 2025
August 1, 2025
7 months
April 14, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measure
Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments.
Within 4 weeks
Secondary Outcomes (1)
Secondary Outcome Measure
Within 52 weeks
Study Arms (3)
Eveotox
EXPERIMENTALEveotox, 20 Units, divided into five injections into the glabellar area. Administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles.
OnabotulinumtoxinA (Botox )
ACTIVE COMPARATORBotox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units).
Placebo
PLACEBO COMPARATORPlacebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units)
Interventions
Rcombinant botulinum toxin type A for injection（Eveotox)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 22, 2025
Study Start
April 30, 2025
Primary Completion
December 1, 2025
Study Completion (Estimated)
August 1, 2026
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share