The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Huons

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glabellar Lines

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02961673

HU-014_P1/2

Details and patient eligibility

About

A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines

Enrollment: 57 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely

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 including fascioplasty, Prosthesis implantation within 6 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: Double Blind

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57 participants in 2 patient groups

HU-014 Inj(Phase 1 and 2)

Experimental group

Description:

HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)

Treatment:

Biological: HU-014 Inj

Botox Inj(Phase 2)

Active Comparator group

Description:

Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)

Treatment:

Biological: Botox Inj