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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rcombinant botulinum toxin type A for injection(Eveotox) | Biological | Rcombinant botulinum toxin type A for injection(Eveotox) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure | Incidence of serious adverse events and drug-related adverse events during the study. | Within 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danhua Lin | Contact | 15811460241 | danhua.lin@jhm-biopharma.com | |
| Lei Wang | Contact | lei.wang@jhm-biopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China | ||
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Biological: Rcombinant botulinum toxin type A for injection (Eveotox) Biological: OnabotulinumtoxinA (Botox) Biological: : Placebo
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| OnabotulinumtoxinA (Botox) | Biological | OnabotulinumtoxinA (Botox) |
|
| Placebo | Biological | Placebo |
|
| Peking University First Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | China |
| The Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
| Xianyang Hospital of Yan'an University | Recruiting | Xianyang | Shanxi | China |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Recruiting | Hangzhou | Zhejiang | China |
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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