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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20221419 | Registry Identifier | www.chinadrugtrials.org.cn |
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This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Single injection with YY001 in glabellar lines |
|
| Active-Controlled Group | Active Comparator | Single injection with BOTOX® in glabellar lines |
|
| Placebo-Controlled Group | Placebo Comparator | Single injection with placebo in glabellar lines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YY001 | Biological | Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection | Within 28 days | |
| Phase1:The incidence rate of injection site reaction within 28 days after injection | Within 28 days | |
| Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection | Within 28 days | |
| Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown | A response rate is defined as a subject who achieves a score of 0 or 1 in GL severity at maximum frown and at least 2 grades improvement from baseline by investigator's assessment | 28 days |
| Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection | within 12 weeks | |
| Phase2:The incidence rate of injection site reaction within 12 weeks after injection | within 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingfeng Li | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China | |||
| The First affiliated Hospital of Chongqing Medical University |
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Placebo and active controlled
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Double-blinded
| OnabotulinumtoxinA | Biological | Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site. |
|
| Placebo | Biological | Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site. |
|
| Chongqing |
| Chongqing Municipality |
| China |
| Nanfang Hospital,Southern Medical University | Guangzhou | Guangdong | China |
| Shanghai Ninth People's Hospital,Shanghai JiaoTong University school of Medicine | Shanghai | Shanghai Municipality | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 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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