Glabellar Frown Lines
Conditions
Brief summary
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines
Interventions
BIOLOGICALHutox Inj
Hutox Inj(Clostridium botulinum type A)
BIOLOGICALBotox Inj
Botox Inj(Clostridium botulinum type A)
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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 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 | Description |
|---|---|---|
| FWS(Facial Wrinkle Severity) Improvement at glabellar line | 4 Weeks | Change from Baseline of Glabellar Lines improvement rate(Frown) |
Countries
South Korea
Outcome results
None listed