A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
NCT Number: NCT06583486
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Moderate to Severe Glabellar Lines
Interventions: BIOLOGICAL: Rcombinant botulinum neurotoxin type A for injection (YY001)
Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 488
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-19
Completion Date: 2025-08-20
Locations: 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, Hongqing, China|Tianjin Medical University General Hospital, Tianjin, China

Summary:
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.

Primary Outcome Measures: Incidence of serious adverse events and drug-related adverse events during the study., Up to 64 weeks
Secondary Outcome Measures: 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.|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&amp;#39; score of GL severity at maximal frown on the investigator's assessment return to the baseline., Up to 64 weeks