To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
272
Single administration, Day 0, 20 units
Single administration, Day 0, 20 units
Hugel
Seoul, South Korea
RECRUITINGResponder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection
Time frame: Baseline to week 4
Responder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection
Time frame: Baseline to week 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
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Time frame: Baseline to week 4, 8, 12, 16