Evaluating HU-045 for treating frown lines
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or Severe Glabellar Lines
This study is testing a new treatment called HU-045 to see if it works better than Xeomin® for reducing frown lines in people with moderate to severe wrinkles.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Huons Biopharma Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06205797 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of HU-045 compared to Xeomin® in patients with moderate to severe glabellar lines. It is a multicenter, double-blind, randomized, parallel, active-controlled Phase III trial. Participants will be evaluated based on their facial wrinkle severity and will receive either HU-045 or Xeomin® to determine which treatment is more effective in reducing frown lines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 with moderate to severe frown lines as assessed by a facial wrinkle scale.
Not a fit: Patients with certain neurological disorders, facial asymmetry, or a history of specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide patients with a more effective option for reducing the appearance of frown lines.
How similar studies have performed: Other studies have shown success with similar injectable treatments for glabellar lines, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Saeroarum Han
- Email: saeroarum@huonsbiopharma.com
- Phone: 82-70-7492-6032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.