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New botulinum toxin aims to smooth frown lines in phase 2 trial

NCT ID NCT06481475

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests a new injection called YY003, a recombinant botulinum neurotoxin type A, for treating moderate to severe frown lines between the eyebrows (glabellar lines) in adults. Participants receive a single set of small injections into five points between the brows. The trial measures how well the treatment reduces frown line severity and tracks any side effects, including immune responses.

What this could mean

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

Active substance
YY003 (recombinant botulinum neurotoxin type A)
What this could lead to
If successful, YY003 could offer a new option for temporarily smoothing frown lines, potentially with fewer side effects than current botulinum toxin products.
What could go wrong
This is an early phase 2 study with only 149 participants, so results may not apply to everyone. As with any injection, risks include bruising, pain, or temporary muscle weakness.

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

153 people

The number who actually took part.

Started

Jan 2025

Finished

Dec 2025

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

18 years and older

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: 1. Participants (male or female) must be ≥18 years old, at the time of signing the informed consent. 2. At screening and baseline, participants must have moderate to severe glabellar lines at maximum frown (grade 2 or 3 on the relevant 4-point scale), as assessed by both the investigator and the participant. 3. Male or female (inclusive of all gender identities) participants are eligible to participate if they agree to practice adequate contraceptive methods during the study period and for at least 3 months after the study drug administration. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 4. Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 5. Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator. Exclusion Criteria: 1. Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype. 2. A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline. 3. A history or presence of facial nerve palsy at screening or baseline. 4. A positive HIV, hepatitis B or hepatitis C test at screening. 5. History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research. 6. History of drug or alcohol abuse. 7. History or presence of epilepsy. 8. Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study. 9. Female who is pregnant or breast feeding. 10. Abnormal laboratory tests that, in the Investigator's assessment, are not appropriate for participation in this study. 11. Participation in an investigational device or drug study within 30 days or 5 half-lives (whichever is longer) prior to screening. 12. Study center personnel, close relatives of the study center personnel, employees or close relatives of employees at the sponsor company.

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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

  • Dermatology Institute of Victoria

    Melbourne, Victoria, 3141, Australia

  • Skin Health Institute

    Melbourne, Victoria, 3053, Australia

  • St George Dermatology & Skin Cancer Centre

    Sydney, New South Wales, 2217, Australia

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