Moderate to Severe Glabellar LinesPhase 2NCT06481475
A Study to Investigate the Safety and Efficacy of YY003 in Adults With Moderate to Severe Glabellar Lines
A Phase 2 study testing YY003 in people with Moderate to Severe Glabellar Lines, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 3 sites in Australia.
Trial summary
The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- YY003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 3 sitesAustralia
- Study dates
- 9 Jan 2025to 28 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
- 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.
- 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.
- Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.
Who cannot join
- Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype.
- A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline.
- A history or presence of facial nerve palsy at screening or baseline.
- A positive HIV, hepatitis B or hepatitis C test at screening.
- History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research.
- History of drug or alcohol abuse.
Show all 12Show fewer
- History or presence of epilepsy.
- Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study.
- Female who is pregnant or breast feeding.
- Abnormal laboratory tests that, in the Investigator's assessment, are not appropriate for participation in this study.
- Participation in an investigational device or drug study within 30 days or 5 half-lives (whichever is longer) prior to screening.
- Study center personnel, close relatives of the study center personnel, employees or close relatives of employees at the sponsor company.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Skin Health Institute
Melbourne, Victoria, 3053
Dermatology Institute of Victoria
Melbourne, Victoria, 3141
St George Dermatology & Skin Cancer Centre
Sydney, New South Wales, 2217
About this study
Official title: A Randomized Double-blind Vehicle-controlled Parallel-dose Phase II Study Evaluating the Safety and Efficacy of a Recombinant Botulinum Neurotoxin Type A Injection (YY003) for the Treatment of Moderate to Severe Glabellar Lines in Adults
The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- YY003, Vehicle Control
- Keywords
- YY003, Botulinum Toxin, Glabellar Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY003Biological
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Vehicle ControlBiological
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
| Study group | Role | What they receive |
|---|---|---|
| Low dose YY003 | Experimental | Participants will receive a single dose over 5 injection sites on Day 1. Receives: Biological: YY003 |
| High dose YY003 | Experimental | Participants will receive a single dose over 5 injection sites on Day 1. Receives: Biological: YY003 |
| Vehicle control | Placebo comparator | Participants will receive a single dose over 5 injection sites on Day 1. Receives: Biological: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs)
Measured: within 4 weeks post-treatment
Efficacy: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from baseline, on both the investigator's assessment and the participant's self-assessmenti of glabellar line severity at maximum frown
Measured: at Week 4 post-treatment visit
Secondary outcomes (1)
Incidence of anti-drug antibodies and neutralizing antibodies
Measured: Within 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start9 Jan 2025
- Primary completion22 Oct 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481475
- Sponsor's protocol ID
- YY003-001-US01
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Vehicle-controlled Parallel-dose Phase II Study Evaluating the Safety and Efficacy of a Recombinant Botulinum Neurotoxin Type A Injection (YY003) for the Treatment of Moderate to Severe Glabellar Lines in Adults
- ClinicalTrials.gov ID
- NCT06481475
- Acronym / sponsor ID
- YY003-001-US01
- Conditions
- Moderate to Severe Glabellar Lines
- Keywords
- YY003, Botulinum Toxin, Glabellar Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose YY003 | Experimental | Biological: YY003Participants will receive a single dose over 5 injection sites on Day 1. |
| High dose YY003 | Experimental | Biological: YY003Participants will receive a single dose over 5 injection sites on Day 1. |
| Vehicle control | Placebo comparator | Biological: Vehicle ControlParticipants will receive a single dose over 5 injection sites on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
- 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.
- 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.
- Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.
Key exclusion criteria (12 listed)
- Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype.
- A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline.
- A history or presence of facial nerve palsy at screening or baseline.
- A positive HIV, hepatitis B or hepatitis C test at screening.
- History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YY003Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site. | Biological | High dose YY003, Low dose YY003 |
| Vehicle ControlSingle treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site. | Biological | Vehicle control |
Primary outcome
Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs)
Time frame: within 4 weeks post-treatment
Efficacy: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from baseline, on both the investigator's assessment and the participant's self-assessmenti of glabellar line severity at maximum frown
Time frame: at Week 4 post-treatment visit
1 secondary outcome
Incidence of anti-drug antibodies and neutralizing antibodies
Time frame: Within 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Moderate to Severe Glabellar Lines
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YY003 in people with Moderate to Severe Glabellar Lines, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs) (time frame: within 4 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.