ET-01 in Subjects With Lateral Canthal Lines, LCL-210 (NCT04985916) | Clinical Trial Compass
CompletedPhase 2
ET-01 in Subjects With Lateral Canthal Lines, LCL-210
United States280 participantsStarted 2021-07-19
Plain-language summary
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Who can participate
Age range25 Years – 65 Years
SexALL
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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 a mirror (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 an active dermal response during the course of the study
* female subjects of childbearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
* female subjects of childbearing potential must utilize one of the following methods of birth control throughout the study: intra-uterine device (IUD), diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 3 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. 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 free…