Glabellar Lines
Conditions
Brief summary
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
Interventions
BIOLOGICALHU-014 Inj
Clostridium botulinum type A
BIOLOGICALBotox Inj
Clostridium botulinum type A
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Facial Wrinkle Scale (FWS) score \> 2 when Subject knits brow extremely
Exclusion criteria
* Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.) * From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks * Subject who has skin disorder including infection and scar on injection site * Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc. * Subject 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1) | Week 4 |
| Change from Baseline of Glabellar Lines improvement rate(Frown) | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| change from Baseline of Glabellar Lines improvement rate (Not frown) | Week4, Week 8, Week 12 |
| Assessment of Columbia Suicide Severity Rating Scale(C-SSRS) | 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 | Week 4, Week 8, Week 12 |
| Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment | Week 4, Week 8, Week 12 |
| change from Baseline of Glabellar Lines improvement rate (Frown) | Week 8, Week 12 |
Countries
South Korea
Outcome results
None listed