New wrinkle treatment could be as easy as a shot
NCT ID NCT07321834
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 study tests AI-09, a ready-to-use liquid botulinum toxin, for treating moderate to severe frown lines between the eyebrows. About 68 adults aged 20 to 70 will receive either AI-09 or an inactive placebo injection. The goal is to see if AI-09 safely and effectively reduces the appearance of these lines.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AI-09 (ready-to-use liquid botulinum toxin)
- What this could lead to
- If it works, this could offer a more convenient, ready-to-use option for temporarily reducing frown lines.
- What could go wrong
- This is an early Phase 2 study with only 68 participants, so results may not confirm effectiveness or safety. As with any botulinum toxin, temporary bruising, headache, or eyelid drooping are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
68 people
The number who actually took part.
- Started
-
Dec 2025
- Expected to finish
-
Feb 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
-
Delricht Research
New Orleans, Louisiana, 70115, United States
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Research Institute of the Southeast, Inc.
West Palm Beach, Florida, 33401, United States
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Research Your Health
Plano, Texas, 75093, United States
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Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New wrinkle treatment aims to rival botox in Head-to-Head trial
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- New frown line combo treatment under study
- New Frown-Line treatment shows promise in large trial