This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
318
Chung-Ang Univ. Hospital
Seoul, Dongjak-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: Week 4
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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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 7-grade score (1 to 7) where 1= very dissatisfied 7=very satisfied
Time frame: Week 4, 8, 12, 16