To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)

Launched by HUONS BIOPHARMA · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HU-045 for reducing glabellar lines, which are the wrinkles that form between your eyebrows when you frown. The trial is currently looking for participants aged 19 to 65 who have moderate to severe wrinkles in this area. To be eligible, you must be in good health and not have certain medical conditions, such as serious nerve or muscle disorders, bleeding issues, or recent facial surgeries. It's important that you fully understand the study and agree to participate by signing an informed consent form.

Participants in the trial will receive either HU-045 or a standard treatment called Xeomin® to see which one works better for reducing these wrinkles. The study is double-blind, meaning neither you nor the researchers will know which treatment you receive, helping to ensure fairness in results. If you join the trial, you can expect regular visits for assessments and to monitor your progress. Remember, the trial is also excluding individuals with certain health conditions or those taking specific medications, so it's essential to discuss your medical history with the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.