Phase 2 of HU-045 in Glabellar Lines
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HU-045 group 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
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
Other Names:
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| Active Comparator: Xeomin® group 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®
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of participants whose glabellar lines at maximal frown are improved ≥ 2-grade improvement from baseline of Facial Wrinkle Scale(FWS) and at maximum frown after injection. [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
- Percentage of participants whose glabellar lines at maximal frown are improved [Week8, Week12]
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]
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]
Participants will rate their overall satisfaction by answering the question on a Questionnaire using 7-point scale. A "Satisfaction" is defined as 6 and/or above.
- Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade [Week4, Week8, Week12]
Subjects will assess their Galbellar Lines with on a 9-point scale from -4 to 4.
Eligibility Criteria
Criteria
Inclusion Criteria:
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2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
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Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.
Exclusion Criteria:
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Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
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Infection, dermatological condition or scar at the treatment injection sites
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Subject who has marked facial asymmetry
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History of facial nerve palsy or eyebrow/eyelid ptosis
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History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
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History of malignant tumor within 5 years (except for basal cell carcinoma
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Any disease and condition that, in the view of the investigator, would interfere with study participation
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Subject who has been treated with any botulinum toxin drug within 6 months
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Subject who takes skeletal muscle relaxants,
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Subject who takes a anticoagulant, antiplatelet, NSAIDs, Vitamin E of over 1,000IU/day (except for low dose aspirin)
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From screening,
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Subject who have positive results of HIV, Syphilis, HBV, HCV
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Drug Hypersensitivity
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Subjects who have hypersensitivity reaction to investigational drug or local anesthetics
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History of Anaphylaxis or severe combined allergy disease
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Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
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Pregnant and lactating women
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Fertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.
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Participant who has been treated with any investigational drug within 30 days from screening
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Subject who are not eligible for this study based on investigator's judgement.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Huons Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HU-045_P2