A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
NCT ID: NCT06499688
Last Updated: 2024-07-24
Study Results
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Basic Information
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COMPLETED
PHASE3
529 participants
INTERVENTIONAL
2023-12-28
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group
Single injection with Rcombinant botulinum neurotoxin type A for injection(YY001) in glabellar lines
Rcombinant botulinum neurotoxin type A for injection (YY001)
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Active-Controlled Group
Single injection with BOTOX® in glabellar lines
OnabotulinumtoxinA
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Placebo-Controlled Group
Single injection with placebo in glabellar lines
Placebo
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Interventions
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Placebo
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Rcombinant botulinum neurotoxin type A for injection (YY001)
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
OnabotulinumtoxinA
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Eligibility Criteria
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Inclusion Criteria
2. At screening and baseline, moderate to severe glabellar lines (grade of 2 or 3 on the 4-point Scale) at maximal frown as assessed by both the Investigator and the participant on-site.
3. Agree to participate in the study and sign the informed consent form.
4. At the discretion of the investigator, the participants can comply with the protocol requirements.
5. Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. Female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the administration of study drug or a urine pregnancy test examination must be negative 3 days prior to the administration of study drug.
Note:
1. Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason).
2. Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones \[oral, patch, ring, injections, implants\], barrier methods \[diaphragm, cervical cap, sponge, condom.
Exclusion Criteria
2. Previous cosmetic manipulation of the area between the eyebrows, within 12 months prior to screening; implantation of autologous fat or any permanent material; history of upper face lifting or semi-permanent prosthetic fillers, etc.; or plan to undergo upper face cosmetic manipulation during the study period (note: except for study drug injections);
3. Use of any botulinum toxin within 6 months prior to baseline, or planned use of botulinum toxin during the study (note: except for use of investigational drugs at the study site).
4. Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants (e.g., heparin, coumarins, non-vitamin K antagonists, oral anticoagulants within 1 week prior to baseline.
5. Use of medications that affect neuromuscular transmission within 4 weeks prior to baseline, including but not limited to: muscarinic agents, aminoglycosides, anticholinergic agents, benzodiazepines.
6. At screening and baseline, skin abnormalities at the injection site
7. Inability to substantially lessen glabellar lines by physically spreading them apart, as determined by the investigator.
8. Ptosis, significant facial asymmetry, excessive skin laxity at screening or baseline, or a history of any of the above.
9. A history of facial nerve palsy.
10. History or presence of such diseases that interfere with neuromuscular function, including, but not limited to: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis; diseases or a history of such diseases that can cause localized neuromuscular function, including, but not limited to: swallowing/breathing difficulties, diplopia, angle-closure glaucoma, significant drooping of the eyes and eyebrows, or flaccidity of the skin/excessive weakness or weakness of the corrugate and/or procerus;
11. Have other concomitant diseases, including but not limited to cardiovascular, respiratory, gastrointestinal, endocrine, and other systemic diseases, malignant tumors, and immunodeficiencies, which are assessed by the investigator to be unsuitable for participation in clinical research.
12. History of drug or alcohol abuse.
13. History or presence of epilepsy.
14. Female who is pregnant or breast feeding.
18 Years
65 Years
ALL
No
Sponsors
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Chongqing Claruvis Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yan Wu
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Guangdong Second People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
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
Chongqing, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
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Other Identifiers
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CTR20233901
Identifier Type: REGISTRY
Identifier Source: secondary_id
YY001-001-Ⅲ-REFINE
Identifier Type: -
Identifier Source: org_study_id
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