Actively Recruiting
A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines
Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2025-03-21
174
Participants Needed
3
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 use effective contraception during the study and for at least 3 months after treatment
- Provide signed informed consent and agree to study requirements
- Be able 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 study drug or any botulinum toxin serotype
- 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 judged unsuitable for participation by the investigator
- History of drug or alcohol abuse
- History or presence of epilepsy
- Serious mental disorder affecting compliance
- Pregnant or breastfeeding female
- Abnormal lab tests deemed inappropriate for participation
- Participation in another investigational drug or device study within 30 days or 5 half-lives prior to screening
- Study center personnel, close relatives of personnel, or employees or relatives of sponsor company employees
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Sun Xiaoyun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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