Phase
Condition
N/ATreatment
botulinum toxin, Type A
Vehicle
Clinical Study ID
Ages 25-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
able to understand and give written informed consent
25 - 65 years of age
willing to have facial pictures/videos taken per protocol
mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"
moderate to severe Crow's Feet (IGA 3-4) "on contraction"
ability to correctly grade a series of Crow's Feet pictures
moderate to severe Crow's Feet (SSA 3-4) "on contraction"
have adequate vision without the use of eyeglasses to assess facial wrinkles in amirror (contact lenses are OK)
willingness to refrain from the use of facial fillers, retinoids, botulinum toxins,laser treatments, or any product affecting skin remodeling or that might cause anactive dermal response during the course of the study
female subjects of childbearing potential must have a negative urine pregnancy testand be non-lactating at the Baseline visit
female subjects of childbearing potential must utilize one of the following methodsof birth control throughout the study: intra-uterine device (IUD), diaphragm, acondom, a spermicidal gel or foam, oral contraceptives (provided subject has beenutilizing this method for at least 3 months prior to Baseline and has not changedthe brand within this period), or patch, injectable, implantable, or vaginal ringcontraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy) or are in menopause.
subjects should be in good general health as determined by the Investigator and freeof any disease that may interfere with study evaluations or the InvestigationalProduct.
Exclusion
Exclusion Criteria:
history of adverse reactions to any prior botulinum toxin treatments
history of vaccination with botulinum toxin
history of non-response to any prior botulinum toxin treatments
any botulinum toxin treatment anywhere in the prior 6 months
history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time inthe past
history of periocular surgery, brow lift or related procedures
soft tissue augmentation or any procedures affecting the lateral canthal region inthe prior 12 months
dermabrasion or laser treatment in the periocular region in the last 6 months
topical prescription-strength retinoids in the prior 3 months to the treatment area
application of any topical prescription medication to the treatment area within 14days prior to treatment
subjects on clinically significant, concomitant drug therapy (See Section 5.3below).).
present or history of neuromuscular disease, eyelid ptosis, muscle weakness orparalysis
present or history of "dry eye"
hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clottingdisorders
use of systemic aminoglycosides in the week prior to treatment application
participation in another investigational drug trial or receiving any investigationaltreatment(s) within 30 days of Baseline
alcohol or drug abuse within the past 3 years
psychiatric disease interfering with the subject's ability to give informed consent
refusal or inability to comply with the requirements of the protocol for any reason
Study Design
Study Description
Connect with a study center
Eirion Research Site
Scottsdale, Arizona 85255
United StatesSite Not Available
Eirion Research Site
San Diego, California 92121
United StatesSite Not Available
Center for Clinical and Cosmetic Research
Aventura, Florida 33180
United StatesSite Not Available
Eirion Research Site
Aventura, Florida 33180
United StatesSite Not Available
Eirion Research Site
Boca Raton, Florida 33486
United StatesSite Not Available
Skin Care Research, LLc
Boca Raton, Florida 33486
United StatesSite Not Available
Baumann Cosmetic & Research Institute
Miami, Florida 33137
United StatesSite Not Available
Eirion Research Site
Miami, Florida 33137
United StatesSite Not Available
Eirion Research Site
West Palm Beach, Florida 33401
United StatesSite Not Available
Research Institute of the Southeast, LLC
West Palm Beach, Florida 33401
United StatesSite Not Available
Eirion Research Site
Chicago, Illinois 60654
United StatesSite Not Available
DS Research
Louisville, Kentucky 40241
United StatesSite Not Available
Eirion Research Site
Louisville, Kentucky 40241
United StatesSite Not Available
Eirion Research Site
New Orleans, Louisiana 70124
United StatesSite Not Available
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana 70124
United StatesSite Not Available
Eirion Research Site
Glenn Dale, Maryland 20769
United StatesSite Not Available
Eirion Research Site
Clinton Township, Michigan 48038
United StatesSite Not Available
Eirion Research Site
New Brighton, Minnesota 55112
United StatesSite Not Available
Eirion Research Site
New York, New York 10075
United StatesSite Not Available
Eirion Research Site
Exton, Pennsylvania 19341
United StatesSite Not Available
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania 19341
United StatesSite Not Available
Eirion Research Site
Newtown Square, Pennsylvania 19073
United StatesSite Not Available
KGL Skin Study Center
Newtown Square, Pennsylvania 19073
United StatesSite Not Available
Eirion Research Site
Greenville, South Carolina 29615
United StatesSite Not Available
Eirion Research Site
Houston, Texas 77056
United StatesSite Not Available
Eirion Research Site
Plano, Texas 75093
United StatesSite Not Available
Eirion Research Site
Norfolk, Virginia 23502
United StatesSite Not Available
Virginia Clinical Research, Inc.
Norfolk, Virginia 23502
United StatesSite Not Available
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