Moderate to Severe Glabellar LinesPhase 3NCT06937944
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
A Phase 3 study testing Rcombinant botulinum toxin type A for injection（Eveotox) and OnabotulinumtoxinA (Botox) in people with Moderate to Severe Glabellar Lines, run by JHM BioPharma (Tonghua) Co. , Ltd. at 15 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- Rcombinant botulinum toxin type A for injection（Eveotox) and OnabotulinumtoxinA (Botox)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 669 participants
- Where
- 15 sitesChina
- Study dates
- 30 Apr 2025to Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Wang contact
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, Shanxi
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
Official title: 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 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.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- Rcombinant botulinum toxin type A for injection（Eveotox), OnabotulinumtoxinA (Botox), Placebo
- Keywords
- Moderate to Severe Glabellar Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rcombinant botulinum toxin type A for injection（Eveotox)Biological
Rcombinant botulinum toxin type A for injection（Eveotox)
OnabotulinumtoxinA (Botox)Biological
OnabotulinumtoxinA (Botox)
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Eveotox | Experimental | Eveotox, 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. Receives: Biological: Rcombinant botulinum toxin type A for injection（Eveotox) |
| OnabotulinumtoxinA (Botox ) | Active comparator | Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units). Receives: Biological: OnabotulinumtoxinA (Botox) |
| Placebo | Placebo comparator | Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4 weeks
Secondary outcomes (1)
Secondary Outcome Measure
Incidence of serious adverse events and drug-related adverse events during the study.
Measured: Within 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start30 Apr 2025
- Primary completion9 Feb 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Biological: Rcombinant botulinum toxin type A for injection (Eveotox) Biological: OnabotulinumtoxinA (Botox) Biological: : Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 669 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JHM BioPharma (Tonghua) Co. , Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937944
- Sponsor's protocol ID
- JHM03-CT301
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No