NCT04081402
Unknown
Phase 3
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
ConditionsCrow's Feet Lines
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Crow's Feet Lines
- Sponsor
- Huons Co., Ltd.
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
Time Frame: 4 weeks
Study Sites (1)
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