To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Single administration, Day 0, 20 units
Single administration, Day 0, 20 units
Konkuk University Medical Center
Seoul, Korea, South Korea
Adverse event and adverse drug reaction incidence rates
Time frame: Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
Time frame: 16 weeks (during the clinical trial)
Responder 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, 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 maximum frown with investigator's photo assessment 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 Physician's rating line severity
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
Changes in grade by physician's rating line severity for glabellar lines
Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline
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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
Subject's satisfaction rate
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain))
Time frame: Baseline