AI-09 In Subjects With Glabellar Lines, GL-101 (NCT05565950) | Clinical Trial Compass
CompletedPhase 1/2
AI-09 In Subjects With Glabellar Lines, GL-101
United States72 participantsStarted 2022-09-03
Plain-language summary
AI-09 In Subjects with Glabellar Lines
Who can participate
Age range20 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* able to understand and give written informed consent
* willingness to have their pictures taken
* 20 - 70 years of age
* moderate to severe glabellar lines (IGA 2-3) on contraction
* moderate to severe glabellar lines (SSA 2-3) on contraction
* none to mild glabellar lines wrinkles (IGA 0-1) at rest
* willingness to refrain from the use of facial fillers, retinoids, Botox, 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 child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
* female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 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)
* subjects should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product
Exclusion Criteria:
* the inability to substantially lessen glabellar lines by physically spreading them apart
* excessive weakness or atrophy in the …