MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines; Glabellar Lines
• Intervention / Treatment: Drug: MT10109L Dose 1; Drug: MT10109L Dose 2; Drug: MT10109L Dose 1 + Dose 2

Detailed Description

Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study.

Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies.

The safety and efficacy data from the lead-in and this open-label extension will be summarized.

• Study Type: Interventional
• Enrollment (Actual): 957
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-Capitale
    • Jette, Bruxelles-Capitale, Belgium, 1090
      • UZ Brussel
  • Limburg
    • Sint-Truiden, Limburg, Belgium, 3800
      • Medical Skincare
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Pacific Derm
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dr. Shannon Humphrey Inc.
    • Vancouver, British Columbia, Canada, V6H 1K9
      • Project Skin MD LTD
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
      • Dermetics Cosmetic Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Center For Dermatology
  • Ontarion
    • Toronto, Ontarion, Canada, M5R 3N8
      • Sweat clinics of canada
• Germany
  • Darmstadt, Germany, 64283
    • Rosenpark Research
  • Duesseldorf, Germany, 40212
    • Privatpraxis Dr. Hilton & Partner
  • Muenchen, Germany, 80333
    • Hautok and Hautok-cosmetics
  • Muenchen, Germany, 80333
    • Studienzentrum Theatiner46
  • Oberursel, Germany, 61440
    • MediCorium Zentrum fuer Dermatologie und Aesthetik
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Kazan State Medical University
  • Moscow, Russian Federation, 109369
    • Medical Center Capital - Zdorovie LLC
  • Moscow, Russian Federation, 119071
    • Center dermatovenereology and cosmetology
  • Saint-Petersburg, Russian Federation, 194291
    • State Budget Institution of Higher Education North
• United Kingdom
  • Chichester, United Kingdom, PO18 8AN
    • Meyer Clinic
  • Glasgow, United Kingdom, G71 8BB
    • NHS Lanarkshire
  • Sutton Coldfield, United Kingdom, B74 2UG
    • MediZen Premier Aesthetic Clinic
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255-4134
      • Clear Dermatology & Aesthetics Center
  • California
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation
    • Solana Beach, California, United States, 92075-2228
      • Art of Skin MD
  • Florida
    • Bradenton, Florida, United States, 34209-5642
      • Susan H. Weinkle
    • Coral Gables, Florida, United States, 33146-1837
      • Skin Research Institute
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Coleman Center For Cosmetic Dermatologic Surgery
    • New Orleans, Louisiana, United States, 70130-4353
      • Etre Cosmetic Dermatology and Laser Center
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • MD Laser Skin & Vein
  • New York
    • New York, New York, United States, 10016-4974
      • Laser & Skin Surgery Center of New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27612-8106
      • M3 Wake Research Inc.
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Dublin
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch Inc.
    • Austin, Texas, United States, 78746-4720
      • Westlake Dermatology & Cosmetic Surgery - Westlake
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completion of lead-in Phase 3 study;
• 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;
• Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures;
• 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo/MT10109L Dose 1; The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study	Drug: MT10109L Dose 1; MT10109L Dose 1 will be injected into the GL area
Experimental: Placebo/MT10109L Dose 2; The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.	Drug: MT10109L Dose 2; MT10109L Dose 2 will be injected into the LCL area
Experimental: Placebo/MT10109L Dose 1 + Dose 2; The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.	Drug: MT10109L Dose 1 + Dose 2; MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
Experimental: MT10109L Dose 1/Dose 1; The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study.	Drug: MT10109L Dose 1; MT10109L Dose 1 will be injected into the GL area
Experimental: MT10109L Dose 2/Dose 2; The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.	Drug: MT10109L Dose 2; MT10109L Dose 2 will be injected into the LCL area
Experimental: MT10109L Dose 1/Dose 1+2; The participant pool in this arm are from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.	Drug: MT10109L Dose 1 + Dose 2; MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
Experimental: MT10109L Dose 2/Dose 1+2; The participant pool in this arm are from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.	Drug: MT10109L Dose 1 + Dose 2; MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
Experimental: MT10109L Dose 1+2/Dose 1+2; The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.	Drug: MT10109L Dose 1 + Dose 2; MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced Any Adverse Event (AE)	The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.	Baseline to Day 720 or Study Exit
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)	This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.	Baseline to Day 720 or Study exit
Mean Change From Baseline in Pulse Rate (Beats Per Minute)	The outcome reported here is the mean change in pulse rate from baseline to study exit.	Baseline to Day 720 or Study Exit
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)	The outcome reported here is the mean change in Systolic BP from baseline to study exit.	Baseline to Day 720 or Study Exit
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)	The outcome reported here is the mean change in Diastolic BP from baseline to study exit.	Baseline to Day 720 or Study Exit
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)	The outcome reported here is the mean change in respiratory rate from baseline to study exit.	Baseline to Day 720 or Study Exit
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.	Baseline to Day 720 or Study Exit

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): February 16, 2023
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MT10109L-004; 2014-005303-24 (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
• product manufactured in and exported from the U.S.: Yes