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

NCT ID: NCT04143815

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-09-01

Brief Summary

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This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.

This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.

Detailed Description

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Conditions

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Glabellar Frown 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 30U

Experimental group, Dose: 30U

Group Type EXPERIMENTAL

MBA-P01 (Botulinum toxin A)

Intervention Type DRUG

Intramuscular injection, dose varies by groups

MBA-P01 20U

Experimental group, Dose: 20U

Group Type EXPERIMENTAL

MBA-P01 (Botulinum toxin A)

Intervention Type DRUG

Intramuscular injection, dose varies by groups

MBA-P01 10U

Experimental group, Dose: 10U

Group Type EXPERIMENTAL

MBA-P01 (Botulinum toxin A)

Intervention Type DRUG

Intramuscular injection, dose varies by groups

Placebo

Placebo group, Normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intramuscular injection

Interventions

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MBA-P01 (Botulinum toxin A)

Intramuscular injection, dose varies by groups

Intervention Type DRUG

Placebo

Intramuscular injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female over 18 years of age
* Bilaterally symmetrical moderate to severe GL at maximum frown 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

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-AU18GBL208

Identifier Type: -

Identifier Source: org_study_id

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