Status:
RECRUITING
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Lead Sponsor:
JHM BioPharma (Tonghua) Co. , Ltd.
Conditions:
Moderate to Severe Glabellar Lines
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 consist...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
669 Patients enrolled
Trial Details
Trial ID
NCT06937944
Start Date
April 30 2025
End Date
August 1 2026
Last Update
September 2 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
2
Peking University First Hospital
Beijing, Beijing Municipality, China
3
Peking University Third Hospital
Beijing, Beijing Municipality, China
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China