Phase 2 of HU-045 in Glabellar Lines

Study Overview
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Brief Summary
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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

Official Title
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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
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Glabellar Lines

Intervention / Treatment
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* Drug: HU-045
* Drug: Xeomin®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.) 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 Subject who has been treated with any botulinum toxin drug within 6 months Subject who takes skeletal muscle relaxants, Subject who takes a anticoagulant, antiplatelet, NSAIDs, Vitamin E of over 1,000IU/day (except for low dose aspirin) From screening, Subject who have positive results of HIV, Syphilis, HBV, HCV Drug Hypersensitivity 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 Fertile 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HU-045 group<br>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. | Drug: HU-045<br>* HU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use. White powder<br>* Other names: IncobotulinumtoxinA;|
| Active Comparator: Xeomin® group<br>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. | Drug: Xeomin®<br>* Xeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.<br>* Other names: IncobotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants whose glabellar lines at maximal frown are improved | 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. | Week4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants whose glabellar lines at maximal frown are improved | 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. | Week8, Week12 | 
| Percentage of participants whose glabellar lines at resting are improved | 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. | Week4, Week8, Week12 | 
| Subject's satisfaction rate after injection | 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. | Week4, Week8, Week12 | 
| Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade | Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4. | Week4, Week8, Week12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glabellar Lines, HU-045, Huons, HuonsBioPharma, Botulinum toxin