MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines

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

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines; Glabellar Lines
• Intervention / Treatment: Drug: MT10109L; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 415
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dr. Shannon Humphrey Inc.
    • Vancouver, British Columbia, Canada, V6H 1K9
      • Project Skin MD
  • Ontario
    • Toronto, Ontario, Canada, M5R 3N8
      • Sweat clinics of canada
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Bertucci MedSpa Inc.
• Germany
  • Berlin, Germany, 10707
    • RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin
  • Bavaria
    • Munich, Bavaria, Germany, 80333
      • Studienzentrum Theatiner46
  • Hessen
    • Kassel, Hessen, Germany, 34121
      • DRK-Kliniken Nordhessen
  • NRW
    • Düsseldorf, NRW, Germany, 40212
      • Privatpraxis Dr. Hilton & Partner
• United Kingdom
  • England
    • Cheadle, England, United Kingdom, SK8 2BD
      • Saleh Aesthetic Clinic Ltd.
    • London, England, United Kingdom, W1G 7JE
      • Cranley Clinic
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9DT
      • Bermuda Practice
  • West Sussex
    • Chichester, West Sussex, United Kingdom, PO18 8AN
      • Meyer Clinic
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute LLC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Coleman Center For Cosmetic Dermatologic Surgery
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • MD Laser, Skin, & Vein Institute
  • New York
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT10109L Dose 1 + Placebo; MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: MT10109L; MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.; Other Names: NivobotulinumtoxinA; Drug: Placebo; Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
Experimental: MT10109L Dose 1 + MT10109L Dose 2; MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and MT10109L Dose 2 into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: MT10109L; MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.; Other Names: NivobotulinumtoxinA
Placebo Comparator: Placebo; Placebo will be injected into the Glabellar Lines (GL) and into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: Placebo; Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS)	The outcome measured is the percentage of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Duration of Glabellar Line (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)	The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (ie, return to moderate or severe GL severity at maximum frown using the FWS).	Day 1 (first treatment) to Day 180
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)	The percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.	Day 30
The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)	The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.	Day 60
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)	The outcome was measured Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30 The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.	Day 30
Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)	This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.	The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier)
Mean Change From Baseline in Systolic Blood Pressure (BP)	Changes in vital signs: Systolic BP	Baseline to Day 360 (Study exit)
Mean Change From Baseline in Diastolic Blood Pressure (BP)	Changes in vital signs: Diastolic BP	Baseline to Day 360 (Study exit)
Mean Change From Baseline in Pulse Rate	Changes in vital signs: Pulse Rate	Baseline to Day 360 (Study exit)
Mean Change From Baseline in Respiratory Rate	Changes in vital signs: Respiratory Rate	Baseline to Day 360 (Study exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate	Change from baseline for ECG safety population - Heart Rate	Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval	Change from baseline for ECG safety population - PR Interval	Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration	Change from baseline for ECG safety population - QRS duration	Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval	Change from baseline for ECG safety population - QT interval	Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval	Change from baseline for ECG safety population - QTcB interval	Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval	Change from baseline for ECG safety population - QTcF interval	Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval	Change from baseline for ECG safety population - RR interval	Baseline to Day 360
Number of Participants With Binding and Neutralizing Antibodies	Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.	Day 360

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Study Director: SangMi Park, Medytox Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2018
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MT10109L-005; 2014-005301-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No