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New wrinkle treatment could be as easy as a shot

NCT ID NCT07321834

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Center for Clinical and Cosmetic Research

    Aventura, Florida, 33180, United States

  • Delricht Research

    New Orleans, Louisiana, 70115, United States

  • Research Institute of the Southeast, Inc.

    West Palm Beach, Florida, 33401, United States

  • Research Your Health

    Plano, Texas, 75093, United States

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215, United States

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