A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabell… (NCT06481475) | Clinical Trial Compass
RecruitingPhase 2
A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines
Australia174 participantsStarted 2025-01-09
Plain-language 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 appearance of moderate to severe glabellar lines.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs)
Timeframe: within 4 weeks post-treatment
2
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
. 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.
. History or presence of epilepsy.
. Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study.