Methods |
Randomised, double‐blind (participants and investigator), active‐control, phase I/II trial 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 |
Participants |
57 participants, older than 19 years old, both gender Inclusion Criteria
Exclusion Criteria
Volunteer who has history of any diseases following (myasthenia gravis, Eaton‐Lambert syndrome, amyotrophic lateral sclerosis etc.)
From screening, participant who received plastic surgery including fascioplasty, prosthesis implantation within 6 weeks
Participant who has skin disorder including infection and scar on injection site
Participant who takes a medication including skeletal muscle relaxants, aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
Participant who takes a medication including anticoagulant, antithrombotic drug except low‐dose aspirin (below 325 mg/day)
Any condition that, in the view of the investigator, would interfere with study participation
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Interventions |
Intervention
Comparator:
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Outcomes |
Primary outcomes
Assessment of Treatment‐Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product (Phase 1) [TimeFrame: Week 4]
Change from baseline of glabellar lines improvement rate(frown) [Time Frame: Week 4]
Secondary outcomes
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 collecting 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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Notes |
Sponsor Huons Co., Ltd. This trial finished on April 2018 |