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Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines

NCT ID: NCT04143854

Last Updated: 2021-03-19

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

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-21

Study Completion Date

2020-08-19

Brief Summary

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This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01

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Detailed Description

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Conditions

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Lateral Canthal 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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MBA-P01 24U

Experimental group; Dose: 24U

Group Type EXPERIMENTAL

MBA-P01(Botulinum toxin A)

Intervention Type DRUG

Intramuscular injection; Dose varies by group

MBA-P01 12U

Experimental group; Dose: 12U

Group Type EXPERIMENTAL

MBA-P01(Botulinum toxin A)

Intervention Type DRUG

Intramuscular injection; Dose varies by group

Placebo

Placebo group; normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intramuscular injection; normal saline

Interventions

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MBA-P01(Botulinum toxin A)

Intramuscular injection; Dose varies by group

Intervention Type DRUG

Placebo

Intramuscular injection; normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18 to 65
* Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile as assessed by both investigator and subject using FWS

Exclusion Criteria

* History of facial nerve paralysis
* Any eyebrow or eyelied ptosis as determined by the investigator
Minimum Eligible Age

18 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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Maroubra Medical Centre

Maroubra, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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MT14-AU18LCL209

Identifier Type: -

Identifier Source: org_study_id

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