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New wrinkle treatment aims to rival botox in Head-to-Head trial

NCT ID NCT07622004

Symptom relief Sponsor: INIBIO Co., Ltd. Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 trial tests whether a new botulinum toxin type A injection, called INI101, works as well as Botox for treating moderate to severe frown lines between the eyebrows. About 292 adults aged 19 to 65 with at least moderate lines at maximum frown will receive a single dose of either INI101 or Botox. The main goal is to see how many people have improved wrinkle appearance after 4 weeks, as judged by a doctor using a standard scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin type A (INI101)
What this could lead to
If INI101 works as well as Botox, it could offer a new, possibly more affordable option for treating frown lines.
What could go wrong
This is a single-dose study in 292 adults. Results may not apply to repeated use or other wrinkle areas. Side effects like temporary eyelid droop or bruising 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

292 people

The number who actually took part.

Started

May 2021

Finished

Mar 2022

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

19 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Adult male or female participants aged between 19 and 65 years old. 2. Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization. 3. Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them. 4. Participants who can understand and comply with the procedures and visit schedules of the study. Exclusion Criteria: 1. Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.) 2. History of blepharoplegia or ptosis 3. Prominent facial asymmetry 4. Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands 5. Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening 6. Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin \[325 mg/day or less\] administered for antithrombotic purposes is acceptable) 7. Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device 8. Participants deemed ineligible for this study for other reasons based on the investigator's judgment

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As listed by the trial registrant

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

Glabellar lines

Contacts and locations

Locations

  • INIBIO Co., Ltd.

    Seoul, South Korea

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