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

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or Severe Glabellar Lines

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

Study Overview

• Status: Recruiting
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: HU-045; Drug: Xeomin®

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Saeroarum Han; Phone Number: 82-70-7492-6032; Email: saeroarum@huonsbiopharma.com
• Study Contact Backup: Name: Jiwon Kim; Phone Number: 82-70-7492-6074; Email: jw.kim@huonsbiopharma.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangbuk Samsung Hospital
    • Contact: Kim; Phone Number: 82-2-2001-2241; Email: susini@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: IncobotulinumtoxinA
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: IncobotulinumtoxinA

What is the study measuring?

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, Week16
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, Week16
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; (1 = very unsatisfied, 2 = un satisfied, 3 = slightly dissatisfied, 4 = average, 5 = slightly satisfied, 6 = Satisfaction, 7 = very satisfied	Week4, Week8, Week12, Week16
Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade	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	Week4, Week8, Week12, Week16

Collaborators and Investigators

• Sponsor: Huons Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: HU-045_P3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No