To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
292
Single administration, Day 0, 20 units
Single administration, Day 0, 20 units
INIBIO Co., Ltd.
Seoul, South Korea
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
Time frame: Baseline to week 4
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
Time frame: Baseline to week 8, 12, 16
Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
Time frame: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment
Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
Time frame: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
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Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
Time frame: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines as assessed by the subject
Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline.
Time frame: Baseline to week 4, 8, 12, 16
Subject's satisfaction
Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration.
Time frame: Baseline to week 4, 8, 12, 16