MEDITOXIN® in Treatment of Crow's Feet Line

NCT ID: NCT03317574

Last Updated: 2019-03-27

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

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-17

Study Completion Date

2018-05-14

Brief Summary

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to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line

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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MEDITOXIN

Group Type EXPERIMENTAL

botulinum toxin type A

Intervention Type DRUG

24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas

BOTOX

Group Type ACTIVE_COMPARATOR

botulinum toxin type A

Intervention Type DRUG

24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas

Interventions

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botulinum toxin type A

24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas

Intervention Type DRUG

botulinum toxin type A

24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas

Intervention Type DRUG

Other Intervention Names

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MEDITOXIN BOTOX

Eligibility Criteria

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Inclusion Criteria

* Male or female of at least 20 to 65 years old
* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria

* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Patients who have bleeding tendency or taking anti-coagulant
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT01-KR17CFL903

Identifier Type: -

Identifier Source: org_study_id

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