To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
Recruiting now · Phase 3
Conditions studied: Glabellar Lines
In brief
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
Key facts
- Study ID
- NCT06205797
- Run by
- Huons Biopharma
- People needed
- 312
- Starts
- 2024-06-20
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2024-10-03
Who can join
Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 19 Years to 65 Years(Adult, Older Adult)
- 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
- Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.
You may not qualify if…
- Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- History of bleeding disorder
- Infection, dermatological condition or scar at the treatment injection sites
- Subject who has marked facial asymmetry
- History of facial nerve palsy or eyebrow/eyelid ptosis
- History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
- History of malignant tumor within 5 years (except for basal cell carcinoma
- Any disease and condition that, in the view of the investigator, would interfere with study participation
- History of alcohol or drug addiction
- Subject who has been treated with any botulinum toxin drug within 6 months
- Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening
- Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)
- A person who has received a retinoid series of medications during the following period as of the time of screening
- Subjects who have hypersensitivity reaction to investigational drug or local anesthetics
- History of Anaphylaxis or severe combined allergy disease
- Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
- Pregnant and lactating women F- ertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.
- Participant who has been treated with any investigational drug within 30 days from screening
- Subject who are not eligible for this study based on investigator's judgement.
Where it is running
- Kangbuk Samsung Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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