To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)

Huons

Status and phase: Enrolling; Phase 3

Conditions: Glabellar Lines

Treatments: Drug: Xeomin®; Drug: HU-045

Study type: Interventional

Funder types: Industry

Identifiers

NCT06205797

HU-045_P3

Details and patient eligibility

About

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

Enrollment: 312 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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312 participants in 2 patient groups

HU-045 group

Experimental group

Description:

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.

Treatment:

Drug: HU-045

Xeomin® group

Active Comparator group

Description:

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.

Treatment:

Drug: Xeomin®