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

NCT ID: NCT04081402

Last Updated: 2019-09-09

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-02-29

Brief Summary

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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

Detailed Description

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Conditions

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Crow's Feet Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HU-014 Inj

Group Type EXPERIMENTAL

HU-014

Intervention Type BIOLOGICAL

Hutox Inj(Clostridium botulinum type A)

Botox Inj

Group Type ACTIVE_COMPARATOR

Botox Inj

Intervention Type BIOLOGICAL

Botox Inj(Clostridium botulinum type A)

Interventions

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HU-014

Hutox Inj(Clostridium botulinum type A)

Intervention Type BIOLOGICAL

Botox Inj

Botox Inj(Clostridium botulinum type A)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jungmin Yu, Researcher

Role: CONTACT

070-7492-5100

Yubeen Choi, Researcher

Role: CONTACT

070-7492-5965

Facility Contacts

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Huon

Role: primary

07074925149

Other Identifiers

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HU-014_P1/3_CFL

Identifier Type: -

Identifier Source: org_study_id

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