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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
488
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.
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
...and 6 more locations
Incidence of serious adverse events and drug-related adverse events during the study.
Time frame: Up to 64 weeks
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).
Time frame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 64 weeks
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