The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Phase 3
- Conditions
- Glabellar Frown Lines
- Registration Number
- NCT03440671
- Lead Sponsor
- Huons Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method FWS(Facial Wrinkle Severity) Improvement at glabellar line 4 Weeks Change from Baseline of Glabellar Lines improvement rate(Frown)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Huons
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Huons🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of