Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07321834
Eligibility Criteria:
Inclusion Criteria:
* 20 to 70 years of age
* moderate to severe glabellar lines (IGA 2 to 3) at maximum frown
* moderate to severe glabellar lines (SSA 2 to 3) at maximum frown
* willingness to refrain from the use of facial fillers, retinoids, Botox®, laser
* female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study
* participants 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
* eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)
* presence or history of "dry eye"
* history of periocular surgery, brow lift or related procedures, or deep dermal scarring
* concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
* history of immunization or hypersensitivity to any botulinum toxin serotype
* history of non-response to any prior botulinum toxin treatments anticipated need for treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment)
* any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* pregnancy or lactation
* application of any topical prescription medication to the treatment area within 14 days prior to treatment
* participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)
* alcohol or drug abuse within the past 3 years
* refusal or inability with the subject's ability to give informed consent or comply with the requirements of the protocol for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT07321834
Study Brief:
Protocol Section:
NCT07321834