Status:
UNKNOWN
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
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Crow's Feet Lines
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT04081402
Start Date
November 1 2018
End Date
February 1 2020
Last Update
September 9 2019
Active Locations (1)
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1
Huons
Seoul, South Korea