To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
262
Single administration, Day 0, 20 units
Single administration, Day 0, 20units
Chung-Ang University Hopspital
Seoul, Dongjak-gu, South Korea
Seoul National University Hospital
Seoul, Jongno-Gu, South Korea
National Medical Center
Seoul, Jung-Gu, South Korea
Eulji General Hospital
Seoul, Nowon-Gu, South Korea
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
Time frame: at 4 weeks post-injection
Safety evaluation in experimental drug treatment group
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.
Time frame: 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity
Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post inejection
Responder rate of improvement in glabellar lines with Subject's improvement assessment
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The catholic university of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-Gu, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-Gu, South Korea
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injections
Subject's satisfaction rate
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection