Actively Recruiting
A Randomized Double-blind Vehicle-controlled Phase II Study Evaluating the Safety and Efficacy of YY003 Injection for Moderate to Severe Glabellar Lines in Adults
Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2025-03-21
174
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and immune response of YY003, a recombinant botulinum neurotoxin injection, in adults with moderate to severe glabellar lines, which are wrinkles between the eyebrows. This randomized, double-blind, vehicle-controlled study includes 174 participants and aims to compare YY003 to a placebo treatment to see if it improves the appearance of these lines. Participants will receive a single intramuscular injection of either a low dose or high dose of YY003 or a vehicle control, administered over five injection sites on Day 1. Each injection delivers a total volume of 0.25 ml, divided as 0.05 ml per site. The study is conducted in two parts and is designed to carefully monitor the effects and safety of the treatment. During the study, participants will be followed for at least 4 weeks after treatment to track any adverse events, including serious or special interest events. Researchers will assess the improvement in wrinkle severity based on both investigator and participant evaluations at maximum frown four weeks post-treatment. Additional monitoring for anti-drug antibodies will occur within 12 weeks. Participants must be able to comply with study requirements and attend scheduled visits throughout the trial.
CONDITIONS
Brief Title
A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older at the time of consent.
- Have moderate to severe glabellar lines at maximum frown (grade 2 or 3 on a 4-point scale) as assessed by both investigator and participant.
- Agree to practice adequate contraception during the study and for at least 3 months after treatment.
- Provide signed informed consent and comply with study requirements.
- Have the time and ability to complete the study and follow instructions as judged by the investigator.
You will not qualify if you...
- Allergy or hypersensitivity to any component of the investigational product or botulinum toxin serotypes.
- History or presence of ptosis, significant facial asymmetry, or excessive dermatochalasis.
- History or presence of facial nerve palsy.
- Positive test for HIV, hepatitis B, or hepatitis C.
- Other diseases deemed unsuitable by the investigator.
- History of drug or alcohol abuse.
- History or presence of epilepsy.
- Serious mental disorder affecting compliance.
- Pregnant or breastfeeding females.
- Abnormal lab tests deemed inappropriate for participation.
- Participation in another investigational study within 30 days or 5 half-lives prior to screening.
- Study center personnel or close relatives of study center or sponsor employees.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intramuscular injection of YY003 or vehicle control into five sites on Day 1.
1 treatment visit (in-person)
Duration - Up to 12 weeks
Participants are monitored for safety and efficacy outcomes up to 12 weeks after treatment.
Visits at Week 4 and additional visits up to Week 12
Trial Site Locations
Total: 3 locations
1
St George Dermatology & Skin Cancer Centre
Sydney, New South Wales, Australia, 2217
Actively Recruiting
2
Skin Health Institute
Melbourne, Victoria, Australia, 3053
Actively Recruiting
3
Dermatology Institute of Victoria
Melbourne, Victoria, Australia, 3141
Actively Recruiting
Research Team
P
Pan Lin
S
Sun Xiaoyun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here