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

Huons

Status and phase: Unknown; Phase 3

Conditions: Crow's Feet Lines

Treatments: Biological: HU-014; Biological: Botox Inj

Study type: Interventional

Funder types: Industry

Identifiers

NCT04081402

HU-014_P1/3_CFL

Details and patient eligibility

About

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

Enrollment: 290 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups

HU-014 Inj

Experimental group

Treatment:

Biological: HU-014

Botox Inj

Active Comparator group

Treatment:

Biological: Botox Inj