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RecruitingNCT06937944Updated Sep 23, 2026

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

A Phase 3 interventional study of Rcombinant botulinum toxin type A for injection(Eveotox) and OnabotulinumtoxinA (Botox) in Moderate to Severe Glabellar Lines, sponsored by JHM BioPharma (Tonghua) Co. , Ltd.. Recruiting at 15 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by JHM BioPharma (Tonghua) Co. , Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
669
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Moderate to Severe Glabellar Lines

Keywords

  • Moderate to Severe Glabellar Lines
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In context

Lead sponsor

JHM BioPharma (Tonghua) Co. , Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
669 participants (estimated)

Study arms

  • Experimental
    Eveotox

    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.

    Biological: Rcombinant botulinum toxin type A for injection(Eveotox)

  • Active comparator
    OnabotulinumtoxinA (Botox )

    Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units).

    Biological: OnabotulinumtoxinA (Botox)

  • Placebo comparator
    Placebo

    Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units)

    Biological: Placebo

Interventions

  • BiologicalRcombinant botulinum toxin type A for injection(Eveotox)

    Rcombinant botulinum toxin type A for injection(Eveotox)

  • BiologicalOnabotulinumtoxinA (Botox)

    OnabotulinumtoxinA (Botox)

  • BiologicalPlacebo

    Placebo

06

What researchers measure

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.

    Time frame: Within 4 weeks

Secondary outcomes

  1. Secondary Outcome Measure

    Incidence of serious adverse events and drug-related adverse events during the study.

    Time frame: Within 52 weeks

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Study locations

15 of 15 sites recruiting
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06937944
Lead sponsor
JHM BioPharma (Tonghua) Co. , Ltd.
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Apr 30, 2025
Primary completion
Feb 9, 2026
Completion
Sep 2026 (estimated)
Last update
Sep 23, 2026

Study contacts

Danhua Lin
Contact
danhua.lin@jhm-biopharma.com
15811460241

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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