Can a new botulinum toxin injection smooth frown lines better?
NCT ID NCT05565950
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests AI-09, an injectable botulinum toxin type A, in people aged 20 to 70 with moderate to severe frown lines between the eyebrows. Researchers compare different doses against a placebo to find the safest and most effective range. The main goal is to see how many participants achieve a visible improvement in frown line severity at four weeks after injection.
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, an injectable botulinum toxin type A
- What this could lead to
- If it works, AI-09 could offer a new option for smoothing frown lines with a possibly longer-lasting or more convenient effect than current botulinum toxin treatments.
- What could go wrong
- This is an early-phase trial with only 96 participants, so the results may not hold up in larger studies. Injections can cause temporary bruising, pain, or drooping eyelids.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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96 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
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May 2024
- Lead sponsor
-
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
-
Accepted
You do not need to have the condition being studied to take part.
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: * 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 target muscle(s) * eyelid ptosis * 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 a 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 * subjects on clinically significant, concomitant drug therapy * participation in another investigational drug trial or receiving any investigational treatment(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
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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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Eirion Research Site
Boca Raton, Florida, 33432, United States
-
Eirion Research Site
Miami, Florida, 33137, United States
-
Eirion Research Site
New Brighton, Minnesota, 55112, United States
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Eirion Research Site
Plano, Texas, 75093, United States
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