Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2019-06-07

Brief Summary

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To determine the efficacy and safety of Botulax® in treatment of crow's feet line

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Detailed Description

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1. Allocation: Randomized
2. Masking: Double Blind

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

DOUBLE

Participants Investigators

Study Groups

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Botulax

Single dose

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Experimental

Botox

Single dose

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

Active Comparator

Interventions

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Botulinum toxin type A

Experimental

Intervention Type DRUG

Botulinum toxin type A

Active Comparator

Intervention Type DRUG

Other Intervention Names

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Botulax Botox

Eligibility Criteria

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Inclusion Criteria

* Male or female of at least 19 to 65 years old
* Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria

* Subject with hypersensitivity to the investigational products or their components
* Female subject who are pregnant or lactating
* Subject who are unable to communicate or follow the instructions
* Subject who are not eligible for this study based on the judgment of an investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes