A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Clostridium botulinum type A
Clostridium botulinum type A
Huons
Seongnam-si, Gyeonggi-do, South Korea
Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
Time frame: Week 4
Change from Baseline of Glabellar Lines improvement rate(Frown)
Time frame: Week 4
Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)
Time frame: Week 4, Week 8, Week 12
change from Baseline of Glabellar Lines improvement rate (Frown)
Time frame: Week 8, Week 12
change from Baseline of Glabellar Lines improvement rate (Not frown)
Time frame: Week4, Week 8, Week 12
Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment
Time frame: Week 4, Week 8, Week 12
Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product
Time frame: Week 4, Week 8, Week 12
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