This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Botulinum toxin Type A
Botulinum toxin Type A
Chung-Ang University Hospital
Seoul, South Korea
Nowon Eulji Medical Center
Seoul, South Korea
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
Time frame: 12 weeks after the injection
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Time frame: 4 weeks after the injection
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Time frame: 4, 8, 12 weeks after the injection
Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)
Time frame: 4, 8, 12 weeks after the injection
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
Time frame: 12 weeks after the injection
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