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

NCT04157686 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MT10109L-0042014-005303-24
• Study Type: interventional
• Target: 957
• Locations: 6 countries
• Sites: 38

Brief Summary

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.

Conditions

Glabellar Lines; Lateral Canthal Lines

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (8)

Placebo/MT10109L Dose 1

EXPERIMENTAL

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

Placebo/MT10109L Dose 2

EXPERIMENTAL

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

Placebo/MT10109L Dose 1 + Dose 2

EXPERIMENTAL

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/Dose 1

EXPERIMENTAL

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 2/Dose 2

EXPERIMENTAL

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 1/Dose 1+2

EXPERIMENTAL

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 2/Dose 1+2

EXPERIMENTAL

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+2/Dose 1+2

EXPERIMENTAL

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

Interventions

MT10109L Dose 1 DRUG

MT10109L Dose 1 will be injected into the GL area

MT10109L Dose 1/Dose 1; Placebo/MT10109L Dose 1

MT10109L Dose 2 DRUG

MT10109L Dose 2 will be injected into the LCL area

MT10109L Dose 2/Dose 2; Placebo/MT10109L Dose 2

MT10109L Dose 1 + Dose 2 DRUG

MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

MT10109L Dose 1+2/Dose 1+2; MT10109L Dose 1/Dose 1+2; MT10109L Dose 2/Dose 1+2; Placebo/MT10109L Dose 1 + Dose 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (38)

Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, 85255-4134, United States

Location

The Eye Research Foundation

Newport Beach, California, 92663-3637, United States

Location

Art of Skin MD

Solana Beach, California, 92075-2228, United States

Location

Susan H. Weinkle

Bradenton, Florida, 34209-5642, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146-1837, United States

Location

Coleman Center For Cosmetic Dermatologic Surgery

Metairie, Louisiana, 70006, United States

Location

Etre Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130-4353, United States

Location

MD Laser Skin & Vein

Hunt Valley, Maryland, 21030, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016-4974, United States

Location

Skin Search of Rochester Inc.

Rochester, New York, 14623, United States

Location

M3 Wake Research Inc.

Raleigh, North Carolina, 27612-8106, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28403, United States

Location

Aventiv Research Dublin

Dublin, Ohio, 43016, United States

Location

Westlake Dermatology & Cosmetic Surgery - Westlake

Austin, Texas, 78746-4720, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

Bellaire Dermatology

Bellaire, Texas, 77401, United States

Location

SkinDC

Arlington, Virginia, 22209, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Medical Skincare

Sint-Truiden, Limburg, 3800, Belgium

Location

Dr. Shannon Humphrey Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Project Skin MD LTD

Vancouver, British Columbia, V6H 1K9, Canada

Location

Pacific Derm

Vancouver, British Columbia, V6H 4E1, Canada

Location

Dermetics Cosmetic Dermatology

Burlington, Ontario, L7N 3N2, Canada

Location

The Center For Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Sweat Clinics of Canada

Toronto, Ontarion, M5R 3N8, Canada

Location

Rosenpark Research

Darmstadt, 64283, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

Location

Hautok and Hautok-cosmetics

München, 80333, Germany

Location

Studienzentrum Theatiner46

München, 80333, Germany

Location

MediCorium Zentrum fuer Dermatologie und Aesthetik

Oberursel, 61440, Germany

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Medical Center Capital - Zdorovie LLC

Moscow, 109369, Russia

Location

Center dermatovenereology and cosmetology

Moscow, 119071, Russia

Location

State Budget Institution of Higher Education North

Saint Petersburg, 194291, Russia

Location

Meyer Clinic

Chichester, PO18 8AN, United Kingdom

Location

NHS Lanarkshire

Glasgow, G71 8BB, United Kingdom

Location

MediZen Premier Aesthetic Clinic

Sutton Coldfield, B74 2UG, United Kingdom

Location

Results Point of Contact

• Title: Young Ryu
• Organization: Medytox Inc.

aab005@medytox.com

+82-2-6901-5424

Study Officials

• SangMi Park

  Medytox Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 8, 2019
• Study Start: October 23, 2019
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4); CA (6); GB (3); BE (2); US (18); DE (5)