New botulinum toxin aims to smooth frown lines in phase 2 trial
NCT ID NCT06481475
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
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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
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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: 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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