The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
NCT ID: NCT02961673
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2016-09-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HU-014 Inj(Phase 1 and 2)
HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
HU-014 Inj
Clostridium botulinum type A
Botox Inj(Phase 2)
Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
Botox Inj
Clostridium botulinum type A
Interventions
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HU-014 Inj
Clostridium botulinum type A
Botox Inj
Clostridium botulinum type A
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
65 Years
ALL
Yes
Sponsors
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Huons Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Huons
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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HU-014_P1/2
Identifier Type: -
Identifier Source: org_study_id
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