Status:
COMPLETED
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Lead Sponsor:
Eirion Therapeutics Inc.
Conditions:
Lateral Canthal Lines
Crow's Feet
Eligibility:
FEMALE
25-65 years
Phase:
PHASE2
Brief Summary
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Detailed Description
This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.
Eligibility Criteria
Inclusion
- females 25 - 65 years of age
- minimal to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet on contraction
- adequate vision to assess facial wrinkles in a mirror
- willingness to refrain from products affecting skin remodeling
- female subjects must be not pregnant and non-lactating
- subjects should be in good general health
Exclusion
- history of adverse reactions to any prior botulinum toxin treatments
- 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
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03839693
Start Date
October 16 2018
End Date
September 19 2019
Last Update
August 23 2022
Active Locations (5)
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1
Baumann Cosmetic & Research Institute
Miami, Florida, United States, 33137
2
Synexus, Inc.
Pinellas Park, Florida, United States, 33781
3
Forefront Dermatology
Louisville, Kentucky, United States, 40202
4
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746