A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines
NCT ID: NCT06481475
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
174 participants
INTERVENTIONAL
2025-01-09
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose YY003
Participants will receive a single dose over 5 injection sites on Day 1.
YY003
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
High dose YY003
Participants will receive a single dose over 5 injection sites on Day 1.
YY003
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Vehicle control
Participants will receive a single dose over 5 injection sites on Day 1.
Vehicle Control
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Interventions
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YY003
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Vehicle Control
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Chongqing Claruvis Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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St George Dermatology & Skin Cancer Centre
Sydney, New South Wales, Australia
Skin Health Institute
Melbourne, Victoria, Australia
Dermatology Institute of Victoria
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YY003-001-US01
Identifier Type: -
Identifier Source: org_study_id
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