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MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

NCT ID: NCT03732833

Last Updated: 2023-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2021-01-25

Brief Summary

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To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.

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Detailed Description

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Conditions

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Lateral Canthal Lines Glabellar 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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MT10109L Dose 1 + Placebo

MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Group Type EXPERIMENTAL

MT10109L

Intervention Type DRUG

MT10109L will be injected into either the LCL, or both the LCL and GL.

Placebo

Intervention Type DRUG

Placebo will be injected into either the GL, or both the LCL and GL.

MT10109L Dose 1 + MT10109L Dose 2

MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Group Type EXPERIMENTAL

MT10109L

Intervention Type DRUG

MT10109L will be injected into either the LCL, or both the LCL and GL.

Placebo

Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be injected into either the GL, or both the LCL and GL.

Interventions

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MT10109L

MT10109L will be injected into either the LCL, or both the LCL and GL.

Intervention Type DRUG

Placebo

Placebo will be injected into either the GL, or both the LCL and GL.

Intervention Type DRUG

Other Intervention Names

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NivobotulinumtoxinA

Eligibility Criteria

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Inclusion Criteria

-Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria

* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
* History of facial nerve palsy.
* Any uncontrolled systemic disease.
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
* Anticipated need for surgery or overnight hospitalization during the study.
* Prior exposure to botulinum toxin of any serotype for any reason.
* Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery).
* Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Females who are pregnant, nursing, or planning a pregnancy during the study.
* Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
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

Principal Investigators

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SangMi Park

Role: STUDY_DIRECTOR

Medytox Inc

Locations

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Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, United States

Site Status

Art of Skin MD

Solana Beach, California, United States

Site Status

Susan H. Weinkle, MD

Bradenton, Florida, United States

Site Status

Etre Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, United States

Site Status

Dermatology and Laser Surgery Center of New York

New York, New York, United States

Site Status

Skin Search of Rochester Inc.

Rochester, New York, United States

Site Status

M3 Wake Research Inc.

Raleigh, North Carolina, United States

Site Status

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Site Status

Aventiv Research Inc.

Dublin, Ohio, United States

Site Status

Westlake Dermatology & Cosmetic Surgery - Westlake

Austin, Texas, United States

Site Status

DermResearch Inc.

Austin, Texas, United States

Site Status

Dr. Jean Carruthers Cosmetic Surgery Inc.

Vancouver, British Columbia, Canada

Site Status

Pacific Derm

Vancouver, British Columbia, Canada

Site Status

Dermetics Cosmetic Dermatology

Burlington, Ontario, Canada

Site Status

Nectar Research Group Inc.

Richmond Hill, Ontario, Canada

Site Status

Rosenpark Research

Darmstadt, Hesse, Germany

Site Status

Hautzentrum Koln - Cologne Dermatology

Cologne, , Germany

Site Status

Hautok and Hautok-cosmetics

München, , Germany

Site Status

MediCorium Zentrum fuer Dermatologie und Aesthetik

Oberursel, , Germany

Site Status

CentroDerm GmbH

Wuppertal, , Germany

Site Status

Countries

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United States Canada Germany

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-005302-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MT10109L-006

Identifier Type: -

Identifier Source: org_study_id

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