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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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)

Group Type EXPERIMENTAL

HU-014 Inj

Intervention Type BIOLOGICAL

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)

Group Type ACTIVE_COMPARATOR

Botox Inj

Intervention Type BIOLOGICAL

Clostridium botulinum type A

Interventions

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HU-014 Inj

Clostridium botulinum type A

Intervention Type BIOLOGICAL

Botox Inj

Clostridium botulinum type A

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huons Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Huons

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HU-014_P1/2

Identifier Type: -

Identifier Source: org_study_id

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