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

Huons

Status and phase: Unknown; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Biological: Botox Inj; Biological: Hutox Inj

Study type: Interventional

Funder types: Industry

Identifiers

NCT03440671

HU-014_P3

Details and patient eligibility

About

A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines

Enrollment: 260 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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 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

---

260 participants in 2 patient groups

Hutox Inj

Experimental group

Description:

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

Treatment:

Biological: Hutox Inj

Botox Inj

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