The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
314
single administration, Day 0, 20U
single administration, Day 0, 20U
Seoul National University Bundang Hospital
Seongnam-si, Gyoung-gi Do, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
Sevrance Medical Center
Seoul, South Korea
St. Paul Hospital
Seoul, South Korea
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection
Time frame: 0 and 4 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection
Time frame: 0, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection
Time frame: 0, 4, 8,12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate confirmed with subject's assessment
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Seoul Asan Medical Center
Seoul, South Korea
Chung-Ang University Yong-San Hospital
Seoul, South Korea
Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection
Time frame: 4, 8, 12 and 16 weeks after the injection
Subject satisfaction rate
Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection
Time frame: 4, 8, 12 and 16 weeks after the injection