Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2018-12-20
2021-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT10109L
MT10109L will be injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
MT10109L
MT10109L will be injected into the LCL.
Placebo
Placebo will be injected into the LCL: initial double-blind treatment on Day 1.
Placebo
Placebo will be injected into the LCL.
Interventions
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MT10109L
MT10109L will be injected into the LCL.
Placebo
Placebo will be injected into the LCL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
* 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.
18 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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Advanced Research Associates
Glendale, Arizona, United States
Eye Research Foundation
Newport Beach, California, United States
Skin Research Institute LLC
Coral Gables, Florida, United States
Coleman Dermatologic Surgery Center
Metairie, Louisiana, United States
MD Laser, Skin, & Vein Institute
Hunt Valley, Maryland, United States
Laser Skin Surgery Center of New York
New York, New York, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
SkinDC
Arlington, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Moscow scientific-practical centre of dermatovenerology and cosmetology
Moscow, , Russia
State Budget Institution of Higher Education North-Western State Medical University named after I.I Mechnikov
Saint Petersburg, , Russia
Expert Aesthetics Ltd
Alderley Edge, Cheshire, United Kingdom
Waverley Medical Practice
Coatbridge, North Lanarkshire, United Kingdom
Medizen Clinic
Sutton Coldfield, West Midlands, 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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2014-005279-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MT10109L-002
Identifier Type: -
Identifier Source: org_study_id
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