This study is a phase 3 clinical trial of multi-center, random, blinded\*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.
The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in China. Those who meet all selection criteria and do not meet any of the exclusion criteria are selected as suitable test subjects. The selected test subjects are blinded and divided into the Botulax test group or the BOTOX test group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects
Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.
Hugel Inc.
Seoul, South Korea
Responder rate of improvement in glabellar lines with Physician's rating of line severity
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown) at the site in week 4.
Time frame: Week 4
Responder rate of improvement in glabellar lines with Physician's rating of line severity
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown)at the site in weeks 1, 8, 12, and 16 after the treatment
Time frame: weeks 1, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at rest with Physician's assessment of severity
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (when at rest) at the site in weeks 1, 4, 8, 12, and 16 after the treatment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (at maximum frown) in weeks 1, 4, 8, 12, and 16 after the treatment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (when at rest) in weeks 1, 4, 8, 12, and 16 after the treatment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
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Responder rate of improvement in glabellar lines with Subject's improvement assessment
The rate of test subjects who self-assess that the treatment is effective (by giving a score of "+2" or higher) in weeks 1, 4, 8, 12, and 16 after the treatment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Subject's satisfaction rate
The rate of test subjects who are satisfied with the treatment effect (test subject's satisfaction rating of 6 - 7) in weeks 1, 4, 8, 12, and 16 after the treatment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment