Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2018-08-16
2019-04-11
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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Vehicle
Vehicle / Placebo formulation
Vehicle
Vehicle Formulation
Dose 1
lower dose of ET-01
botulinum toxin, Type A
botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
Dose 2
higher dose of ET-01
botulinum toxin, Type A
botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Interventions
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Vehicle
Vehicle Formulation
botulinum toxin, Type A
botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
botulinum toxin, Type A
botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating
Exclusion Criteria
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child
25 Years
65 Years
ALL
No
Sponsors
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Eirion Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Klaus Theobald, MD, PhD
Role: STUDY_DIRECTOR
Eirion Therapeutics
Locations
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Baumann Cosmetic & Research Institute
Miami, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Research Institute of the Southeast, LLC
West Palm Beach, Florida, United States
Dermatology NOLA Inc.
Metairie, Louisiana, United States
Westlake Dermatology Clinical Research Center
Austin, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ET-01-LCL-207
Identifier Type: -
Identifier Source: org_study_id
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