Crow's Feet Lines
Conditions
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
Interventions
BIOLOGICALHU-014
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
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4] | 4 weeks |
Countries
South Korea
Contacts
Primary ContactJungmin Yu, Researcher
Backup ContactYubeen Choi, Researcher
Outcome results
None listed