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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20233901 | Registry Identifier | www.chinadrugtrials.org.cn |
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This is a randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin 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 | Single injection with Rcombinant botulinum neurotoxin type A for injection(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 |
|---|---|---|---|---|
| Rcombinant botulinum neurotoxin type A for injection (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 |
|---|---|---|
| The 4th week after treatment, the composite response rate on both the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown. | The composite response rate: The proportion of participants achieving a score of 0 or 1 and a two-grade improvement from the baseline, on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown. Glabellar lines at maximal frown is based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe). | The 4th week after treatment |
| At the 1st week, 8th week, and 12th week after treatment, the composite response rate on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown. | At the 1st week, 8th week, and 12th week after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site. | The response rate: The proportion of participants achieving a score of 0 or 1 and a two-grade improvement of GL severity from the baseline at maximal frown. | At the 1st week, 4th week, 8th week, and 12th week after 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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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. |
|
| The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment and the participant's self-assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment. | The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment and the participant's self-assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site. | At the 1st week, 4th week, 8th week, and 12th week after treatment |
| the severity of GL at rest on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site. | 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 the 1st week, 4th week, 8th week, and 12th week after treatment |
| The duration of GL treatment effect when the maximal frown severity score returned to baseline score. | Within 12 weeks |
| At the 1st week, 4th week, 8th week, and 12th week after treatment, the improvement rate of glabellar lines severity at maximal frown on the participant's self-assessment. | Participant self-assessment of 9 subscales: +4 (complete improvement), +3 (significant improvement), +2 (moderate improvement), +1 (slight improvement), 0 (no change), -1 (minor aggravation), -2 (medium aggravation), -3 (significant aggravation), and-4 (very significant aggravation). Improvement rate is defined as the proportion of participants with + 2 (moderate improvement) or above. | At the 1st week, 4th week, 8th week, and 12th week after treatment |
| At the 1st week, 4th week, 8th week, and 12th week after treatment, the participant's satisfaction. | Satisfaction will be assessed on the 7-grade scale: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat dissatisfied), 4 (reluctantly), 5 (relatively satisfied), 6 (satisfied) and 7 (very satisfied). Calculate the proportion of participants with 6 or above. | At the 1st week, 4th week, 8th week, and 12th week after treatment |
| Incidence of adverse events and serious adverse events within 12 weeks of treatment. | Within 12 weeks of treatment |
| Incidence of injection site reactions within 12 weeks of treatment. | Within 12 weeks of treatment |
| Incidence of anti-drug antibodies and neutralizing antibodies within 12 weeks of treatment. | Within 12 weeks of treatment |
| 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 | Tan | 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 | Chongqing | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| ID | Term |
|---|---|
| D007267 | Injections |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| 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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