A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
Phase 3
- Conditions
- Crow's Feet Lines
- Interventions
- Biological: HU-014Biological: Botox Inj
- Registration Number
- NCT04081402
- Lead Sponsor
- Huons Co., Ltd.
- Brief Summary
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
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 within 48 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HU-014 Inj HU-014 - Botox Inj Botox Inj -
- Primary Outcome Measures
Name Time Method Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4] 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Huons
🇰🇷Seoul, Korea, Republic of