Investigating YY003 for treating moderate to severe glabellar lines

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

This study is testing a new treatment called YY003 to see if it can help reduce the appearance of frown lines in people with moderate to severe wrinkles.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Sydney, New South Wales and 2 other locations)
• Trial ID: NCT06481475 on ClinicalTrials.gov

What this trial studies

This study is a two-part, randomized, double-blind, vehicle-controlled clinical trial involving 174 participants to evaluate the safety and efficacy of YY003 in improving the appearance of moderate to severe glabellar lines. Participants will receive either YY003 or a vehicle control, and their responses will be assessed at maximum frown using a standardized grading scale. The study aims to determine not only the effectiveness of YY003 but also its immunogenicity compared to the control.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe glabellar lines.

Not a fit: Patients with mild glabellar lines or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of glabellar lines, enhancing patients' aesthetic outcomes.

How similar studies have performed: Other studies investigating similar botulinum toxin treatments have shown positive results, indicating a potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Sydney, New South Wales and 2 other locations

• St George Dermatology & Skin Cancer Centre — Sydney, New South Wales, Australia (Recruiting)
• Skin Health Institute — Melbourne, Victoria, Australia (Recruiting)
• Dermatology Institute of Victoria — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Pan Lin

Conditions Moderate to Severe Glabellar Lines; YY003; Botulinum Toxin; Glabellar Lines