MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
NCT ID: NCT04157686
Last Updated: 2024-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
957 participants
INTERVENTIONAL
2019-10-23
2023-02-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
MT10109L Dose 1
MT10109L Dose 1 will be injected into the GL area
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.
MT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL area
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.
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
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.
MT10109L Dose 1
MT10109L Dose 1 will be injected into the GL area
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.
MT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL area
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.
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
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.
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
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.
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
Interventions
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MT10109L Dose 1
MT10109L Dose 1 will be injected into the GL area
MT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL area
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
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
* 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.
19 Years
ALL
No
Sponsors
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Medy-Tox
INDUSTRY
Responsible Party
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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
The Eye Research Foundation
Newport Beach, California, United States
Art of Skin MD
Solana Beach, California, United States
Susan H. Weinkle
Bradenton, Florida, United States
Skin Research Institute
Coral Gables, Florida, United States
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States
MD Laser Skin & Vein
Hunt Valley, Maryland, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Skin Search of Rochester Inc.
Rochester, New York, United States
M3 Wake Research Inc.
Raleigh, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Aventiv Research Dublin
Dublin, Ohio, United States
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas, United States
DermResearch Inc.
Austin, Texas, United States
Bellaire Dermatology
Bellaire, Texas, United States
SkinDC
Arlington, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
UZ Brussel
Jette, Brussels Capital, Belgium
Medical Skincare
Sint-Truiden, Limburg, Belgium
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, Canada
Project Skin MD LTD
Vancouver, British Columbia, Canada
Pacific Derm
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology
Burlington, Ontario, Canada
The Center For Dermatology
Richmond Hill, Ontario, Canada
Sweat Clinics of Canada
Toronto, Ontarion, Canada
Rosenpark Research
Darmstadt, , Germany
Privatpraxis Dr. Hilton & Partner
Düsseldorf, , Germany
Hautok and Hautok-cosmetics
München, , Germany
Studienzentrum Theatiner46
München, , Germany
MediCorium Zentrum fuer Dermatologie und Aesthetik
Oberursel, , Germany
Kazan State Medical University
Kazan', , Russia
Medical Center Capital - Zdorovie LLC
Moscow, , Russia
Center dermatovenereology and cosmetology
Moscow, , Russia
State Budget Institution of Higher Education North
Saint Petersburg, , Russia
Meyer Clinic
Chichester, , United Kingdom
NHS Lanarkshire
Glasgow, , United Kingdom
MediZen Premier Aesthetic Clinic
Sutton Coldfield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-005303-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MT10109L-004
Identifier Type: -
Identifier Source: org_study_id
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