- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157686
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bruxelles-Capitale
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Jette, Bruxelles-Capitale, Belgium, 1090
- UZ Brussel
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Limburg
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Sint-Truiden, Limburg, Belgium, 3800
- Medical Skincare
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British Columbia
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Vancouver, British Columbia, Canada, V6H 4E1
- Pacific Derm
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Vancouver, British Columbia, Canada, V5Z 4E1
- Dr. Shannon Humphrey Inc.
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Vancouver, British Columbia, Canada, V6H 1K9
- Project Skin MD LTD
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Ontario
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Burlington, Ontario, Canada, L7N 3N2
- Dermetics Cosmetic Dermatology
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Richmond Hill, Ontario, Canada, L4B 1A5
- The Center For Dermatology
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Ontarion
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Toronto, Ontarion, Canada, M5R 3N8
- Sweat Clinics of Canada
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Darmstadt, Germany, 64283
- Rosenpark Research
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Duesseldorf, Germany, 40212
- Privatpraxis Dr. Hilton & Partner
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Muenchen, Germany, 80333
- Hautok and Hautok-cosmetics
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Muenchen, Germany, 80333
- Studienzentrum Theatiner46
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Oberursel, Germany, 61440
- MediCorium Zentrum fuer Dermatologie und Aesthetik
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Kazan, Russian Federation, 420012
- Kazan State Medical University
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Moscow, Russian Federation, 109369
- Medical Center Capital - Zdorovie LLC
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Moscow, Russian Federation, 119071
- Center dermatovenereology and cosmetology
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Saint-Petersburg, Russian Federation, 194291
- State Budget Institution of Higher Education North
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Chichester, United Kingdom, PO18 8AN
- Meyer Clinic
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Glasgow, United Kingdom, G71 8BB
- NHS Lanarkshire
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Sutton Coldfield, United Kingdom, B74 2UG
- MediZen Premier Aesthetic Clinic
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Arizona
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Scottsdale, Arizona, United States, 85255-4134
- Clear Dermatology & Aesthetics Center
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California
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Newport Beach, California, United States, 92663-3637
- The Eye Research Foundation
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Solana Beach, California, United States, 92075-2228
- Art of Skin MD
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Florida
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Bradenton, Florida, United States, 34209-5642
- Susan H. Weinkle
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Coral Gables, Florida, United States, 33146-1837
- Skin Research Institute
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Louisiana
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Metairie, Louisiana, United States, 70006
- Coleman Center For Cosmetic Dermatologic Surgery
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New Orleans, Louisiana, United States, 70130-4353
- Etre Cosmetic Dermatology and Laser Center
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Maryland
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Hunt Valley, Maryland, United States, 21030
- MD Laser Skin & Vein
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New York
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New York, New York, United States, 10016-4974
- Laser & Skin Surgery Center of New York
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Rochester, New York, United States, 14623
- Skin Search of Rochester Inc.
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North Carolina
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Raleigh, North Carolina, United States, 27612-8106
- M3 Wake Research Inc.
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Wilmington, North Carolina, United States, 28403
- Wilmington Dermatology Center
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Ohio
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Dublin, Ohio, United States, 43016
- Aventiv Research Dublin
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Texas
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Austin, Texas, United States, 78759
- DermResearch Inc.
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Austin, Texas, United States, 78746-4720
- Westlake Dermatology & Cosmetic Surgery - Westlake
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Bellaire, Texas, United States, 77401
- Bellaire Dermatology
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Virginia
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Arlington, Virginia, United States, 22209
- SkinDC
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Norfolk, Virginia, United States, 23507
- Virginia Clinical Research, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Placebo/MT10109L Dose 1
The participant pool in this arm are from the MT10109L-001 lead-in study, 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
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MT10109L Dose 1 will be injected into the GL area
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Experimental: Placebo/MT10109L Dose 2
The participant pool in this arm are from the MT10109L-002 lead-in study, 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.
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MT10109L Dose 2 will be injected into the LCL area
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Experimental: Placebo/MT10109L Dose 1 + Dose 2
The participant pool in this arm are from the MT10109L-005 and MT10109L-006 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.
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MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
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Experimental: MT10109L Dose 1/Dose 1
The participant pool in this arm are from the MT10109L-001 lead-in study, 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.
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MT10109L Dose 1 will be injected into the GL area
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Experimental: MT10109L Dose 2/Dose 2
The participant pool in this arm are from the MT10109L-002 lead-in study, 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.
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MT10109L Dose 2 will be injected into the LCL area
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Experimental: MT10109L Dose 1/Dose 1+2
The participant pool in this arm are from the from MT10109L-005 lead-in study, 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.
|
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, 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.
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MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
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Experimental: MT10109L Dose 1+2/Dose 1+2
The participant pool in this arm are from the MT10109L-005 and MT10109L-006 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.
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MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants who experienced an adverse event
Time Frame: Baseline to Day 720
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Baseline to Day 720
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Mean change from baseline in pulse rate (beats per minute)
Time Frame: Baseline to Day 720
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Baseline to Day 720
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Mean change from baseline in blood pressure (mm Hg)
Time Frame: Baseline to Day 720
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Baseline to Day 720
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Mean change from baseline in respiratory rate (breaths per minute)
Time Frame: Baseline to Day 720
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Baseline to Day 720
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Number of participants with binding and neutralizing antibodies
Time Frame: Baseline to Day 720
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Baseline to Day 720
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: SangMi Park, Medytox Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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