Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rcombinant botulinum toxin type A for injection（Eveotox), OnabotulinumtoxinA (Botox), Placebo.
- Who it may be relevant to
- Registry conditions: Moderate to Severe Glabellar Lines. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Biological Rcombinant botulinum toxin type A for injection（Eveotox)
Rcombinant botulinum toxin type A for injection（Eveotox) - Biological OnabotulinumtoxinA (Botox)
OnabotulinumtoxinA (Botox) - Biological Placebo
Placebo
Primary outcome measures
- Primary Outcome Measure [Time frame: Within 4 weeks]
Secondary outcome measures (1)
- Secondary Outcome Measure [Time frame: Within 52 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 15 centers
- Peking Union Medical College Hospital — Beijing
- Peking University First Hospital — Beijing
- Peking University Third Hospital — Beijing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- The First Affiliated Hospital of Jinan University — Guangzhou
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
- The First Hospital of Hebei Medical University — Shijiazhuang
- The Third Xiangya Hospital of Central South University — Changsha
- … and 7 more centers
Identifiers
NCT: NCT06937944 · JHM03-CT301