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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Glabellar Lines

In brief

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.

Key facts

Study ID

NCT06937944

Run by

JHM BioPharma (Tonghua) Co. , Ltd.

People needed

669

Starts

2025-04-30

Expected to finish

2026-08-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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