This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, 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. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
269
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, South Korea
Chung-Ang University Hospital
Seoul, Gwangjin-gu, South Korea
Konkuk University Hospital
Seoul, Gwangjin-gu, South Korea
Nowon Eulji Medical Center
Seoul, Nowon-gu, South Korea
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: 4 weeks post injection compared to baseline
Investigator-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: Week 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: Week 4, 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: Week 4, 8, 12, 16
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Pusan National University Hospital
Pusan, Seo-gu, South Korea
Independent photo evaluator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Time frame: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Participant evaluate the level of satisfaction by Patient Satisfaction(PS) 7-grade score(1 to 7) where 1 = very dissatisfied and 7 = very satisfied
Time frame: Week 4, 8, 12, 16