Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

NCT ID: NCT01485601

Last Updated: 2024-02-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-07

Study Completion Date

2012-08-17

Brief Summary

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The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MT10109

Clostridium botulinum toxin type A

Group Type EXPERIMENTAL

MT10109

Intervention Type BIOLOGICAL

Single dose intramuscular injection MT10109 vs Botox®

Botox (registered trade mark)

Clostridium botulinum toxin type A

Group Type ACTIVE_COMPARATOR

MT10109

Intervention Type BIOLOGICAL

Single dose intramuscular injection MT10109 vs Botox®

Interventions

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MT10109

Single dose intramuscular injection MT10109 vs Botox®

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
* Women of childbearing potential must have a negative serum pregnancy test at screening

Exclusion Criteria

* Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
* Patients with an anaphylactic response history to botulinum toxin type A.
* Patients who have been administered botulinum toxin type A within the previous 6 months.
* Pregnant or lactating women.
* Participation in any research study involving drug administration within 90 days preceding enrollment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Principal Investigators

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Peter Foley, Doctor

Role: PRINCIPAL_INVESTIGATOR

Austrailia

Locations

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Melbourne, , Australia

Site Status

Countries

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Australia

Other Identifiers

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MT-GPRT-GL01

Identifier Type: -

Identifier Source: org_study_id

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