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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20240641 | Registry Identifier | www.chinadrugtrials.org.cn |
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This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Five sites will be repeatedly injected with Rcombinant botulinum neurotoxin type A for injection (YY001) at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.The study period is up to 64 weeks, divided into 5 treatment cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rcombinant botulinum neurotoxin type A for injection (YY001) | Biological | Five sites will be injected at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events and drug-related adverse events during the study. | Up to 64 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity. | Glabellar lines at maximal frown are based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe). | At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. |
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Inclusion Criteria:
Note:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wu | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Second People's Hospital | Guangzhou | Guangdong | China | |||
| Nanfang Hospital, Southern Medical University |
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Single-arm and long-term follow-up
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Open-label
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| The proportion of participants who achieve a score of 0 or 1 on the participant's self-assessment and Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site. |
| At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. |
| The respond rate on the investigator's assessment of GL severity at maximal frown. | The respond rate: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from the baseline, on the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown. | At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. |
| The proportion of participants with a decrease of at least 1 grade from the baseline, on the investigator's assessment and the participant's self-assessment individually of GL severity at rest. | The severity of glabellar lines at rest will be assessed according to the 4 grade scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe). | At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. |
| Incidence of anti-drug antibodies and neutralizing antibodies during the study. | Up to 64 weeks |
| The lasting time from a single injection to the participants' score of GL severity at maximal frown on the investigator's assessment return to the baseline. | Up to 64 weeks |
| Guangzhou |
| Guangdong |
| China |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Second Affiliated Hospital Of Xi'an Jiaotong University | Xian | Shanxi | China |
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine | Hangzhou | Zhejiang | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| Beijing Tsinghua Changgung Hospital | Beijing | China |
| Peking Union Medical College Hospital , Chinese Academy of Medical Sciences | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University Third Hospital | Beijing | China |
| Plastic Surgery Hospital, Chinese Academy of Medical Science | Beijing | China |
| The First Affiliated Hospital of Chongqing Medical University | Hongqing | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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