To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
- Registration Number
- NCT06205797
- Lead Sponsor
- Huons Biopharma
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 312
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HU-045 group HU-045 HU-045 Injection group will receive intramuscular injection of HU-045 to a total of 5 glabellar line sites 4 U/0.1ml each. HU-045 will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered. Xeomin® group Xeomin® Xeomin® Injection group will receive intramuscular injection of Xeomin® to a total of 5 glabellar line sites 4 U/0.1ml each. Xeomin® will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered.
- Primary Outcome Measures
Name Time Method Percentage of participants whose glabellar lines at maximal frown are improved Week4 Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the participants whose FWS score is 0 or 1 grade when it's assessed and ≥ 2 grade improvement from baseline will be defined as their glabellar lines are improved.
- Secondary Outcome Measures
Name Time Method Percentage of participants whose glabellar lines at maximal frown are improved Week8, Week12, Week16 Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the participants whose FWS score is 0 or 1 grade when it's assessed and ≥ 2 grade improvement from baseline will be defined as their glabellar lines are improved.Percentage of participants whose glabellar lines at resting are improved Week4, Week8, Week12, Week16 Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at resting; 0=none, 1=mild, 2=moderate or 3=severe.
Only the participants whose FWS score is 0 or 1 grade when it's assessed and ≥ 2 grade improvement from baseline will be defined as their glabellar lines are improved.Subject's satisfaction rate after injection Week4, Week8, Week12, Week16 Participants will rate their overall satisfaction by answering the question on a Questionnaire using 7 point scale. 6 and/or above grade will be defined as the participant is satisfied about their glabellar lines; (1 = very unsatisfied, 2 = un satisfied, 3 = slightly dissatisfied, 4 = average, 5 = slightly satisfied, 6 = Satisfaction, 7 = very satisfied
Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade Week4, Week8, Week12, Week16 Subjects will assess their glabellar Lines with a 9 point scale from -4 to +4;(+4 = 100% improvement, +3 = 75% improvement, +2 = 50% improvement, +1 = 25% improvement, 0 = no change, -1 = 25% worse, -2 = 50% worse, -3 = 75% worse, -4 = 100% worse
Trial Locations
- Locations (1)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of