Actively Recruiting
To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
Led by Huons Biopharma · Updated on 2024-10-03
312
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines
CONDITIONS
Official Title
To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 65 years
- Moderate (score 2) or higher facial wrinkle scale at frown as assessed live by investigator
- Signed informed consent and fully understands the clinical trial
You will not qualify if you...
- History of muscle or nerve diseases such as myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- History of bleeding disorders
- Infection, skin condition, or scar at injection sites
- Marked facial asymmetry
- History of facial nerve palsy or eyelid drooping
- Prior forehead or middle forehead surgery affecting lines
- History of malignant tumor within 5 years (except basal cell carcinoma)
- Any condition interfering with study participation as judged by investigator
- History of alcohol or drug addiction
- Treatment with botulinum toxin within 6 months
- Use of systemic muscle relaxants within 4 weeks before screening
- Taking high doses of anticoagulants, antiplatelets, NSAIDs, or vitamin E within 7 days before treatment (except low-dose aspirin)
- Use of retinoid medications during screening period
- Hypersensitivity to study drug or local anesthetics
- History of severe allergic reactions or anaphylaxis
- Physically untreatable glabellar lines that cannot be spread out
- Pregnant or lactating women; fertile participants not agreeing to contraception
- Treated with any investigational drug within 30 days before screening
- Deemed ineligible by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Saeroarum Han
CONTACT
J
Jiwon Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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