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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
529
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Guangdong Second People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
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).
Time frame: 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.
Time frame: At the 1st week, 8th week, and 12th week after treatment
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.
Time frame: 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.
Time frame: At the 1st week, 4th week, 8th week, and 12th week after treatment
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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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 12 weeks of treatment
Incidence of injection site reactions within 12 weeks of treatment.
Time frame: Within 12 weeks of treatment
Incidence of anti-drug antibodies and neutralizing antibodies within 12 weeks of treatment.
Time frame: Within 12 weeks of treatment