Glabellar Lines
Conditions
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
Interventions
DRUGHU-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: IncobotulinumtoxinA
DRUGXeomin®
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: IncobotulinumtoxinA
Sponsors
Huons Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactSaeroarum Han
Backup ContactJiwon Kim
Outcome results
None listed