To Evaluate HU-045 in the Treatment of Glabellar Lines(Ph... | NCT06205797

NCT06205797

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HU-045 group	Experimental	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
Xeomin® group	Active Comparator	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®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HU-045	Drug	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

Outcomes Module

Primary Outcomes

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 Outcomes

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, Week16

Eligibility Module

Eligibility 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.

Name	Role	Phone	Extension	Email
Saeroarum Han	Contact	82-70-7492-6032		saeroarum@huonsbiopharma.com
Jiwon Kim	Contact	82-70-7492-6074		jw.kim@huonsbiopharma.com