Eveotox injections for 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
This trial tests whether Eveotox injections can reduce moderate to severe glabellar lines in adults aged 18–65 compared with Botox and a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 669 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | JHM BioPharma (Tonghua) Co. , Ltd. Research network |
| Locations | 15 sites (Beijing, Beijing Municipality and 14 other locations) |
| Trial ID | NCT06937944 on ClinicalTrials.gov |
What this trial studies
This Phase 3 program includes a randomized, double-blind, single-injection, active- and placebo-controlled Part 1 and an open-label Part 2 of repeated injections to measure efficacy, safety, and immunogenicity of Eveotox. Participants are compared against onabotulinumtoxinA (Botox) and placebo, with clinical ratings by investigators and patients of glabellar line severity. Key outcomes include wrinkle severity improvement, adverse events, and antibody formation against the drug. The trial is conducted at multiple tertiary hospitals in Beijing and enrolls adults with moderate to severe glabellar lines.
Who should consider this trial
Good fit: Adults aged 18 to 65 with moderate or severe glabellar lines at maximum frown who can attend scheduled visits and meet safety criteria are eligible to participate.
Not a fit: People with known hypersensitivity to botulinum toxin A, recent similar injections within six months, permanent glabellar implants or recent semi-permanent fillers, active injection-site infections, or disqualifying skin disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, Eveotox could provide an effective and safe botulinum toxin A option for reducing moderate to severe glabellar lines, potentially comparable to existing Botox treatments.
How similar studies have performed: OnabotulinumtoxinA (Botox) has a well-established record of success for glabellar lines, while recombinant formulations like Eveotox are newer and have limited phase 3 data published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Beijing, Beijing Municipality and 14 other locations
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
- Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Xianyang Hospital of Yan'an University — Xianyang, Shanxi, China (Recruiting)
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
- Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Danhua Lin
- Email: danhua.lin@jhm-biopharma.com
- Phone: 15811460241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.