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 Number: NCT06499688
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Moderate to Severe Glabellar Lines
Interventions: BIOLOGICAL: Rcombinant botulinum neurotoxin type A for injection (YY001)|BIOLOGICAL: OnabotulinumtoxinA|BIOLOGICAL: Placebo
Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 529
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-28
Completion Date: 2024-05-31
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, 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|Zhejiang Provincial People's Hospital, :Hangzhou, Zhejiang, China|Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine, 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

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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|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