Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
ATGC-110 is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.
Xeomin® is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.
Nowon Eulji Medical Center
Seoul, South Korea
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Time frame: 4 weeks after the administration
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at weeks 8, 12, and 16 compared to the baseline
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Time frame: 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at rest according to the investigator's on-site evaluation at weeks 4, 8, 12, and 16 compared to the baseline
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Time frame: 4, 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at maximum frown evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
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Time frame: 4, 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at rest evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown according to the investigator's on-site evaluation at week 4, 8, 12, and 16
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at rest according to the investigator's on-site evaluation at week 4, 8, 12, and 16
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at rest evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is improved ≥ 2 grade improvement according to the subject's evaluation at week 4, 8, 12, and 16
Subjects will assess their glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Time frame: 4, 8, 12 and 16 weeks after the administration
Evaluation of subjects' satisfaction at weeks 4, 8, 12, and 16
If the subject's satisfaction evaluation score is 6 points or higher, it is evaluated as satisfactory.
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is imporved ≥ 2 grade improvement at maximal frown according to the investigator's on-site and subject's evaluation at weeks 4, 8, 12, and 16
If the glabellar line score evaluated by the subject is +2 points or higher, it is evaluated as improved
Time frame: 4, 8, 12 and 16 weeks after the administration