Phase 2 of HU-045 in 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

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of
      • Chung-Ang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.)
• 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
• Subject who has been treated with any botulinum toxin drug within 6 months
• Subject who takes skeletal muscle relaxants,
• Subject who takes a anticoagulant, antiplatelet, NSAIDs, Vitamin E of over 1,000IU/day (except for low dose aspirin)
• From screening,
• Subject who have positive results of HIV, Syphilis, HBV, HCV
• Drug Hypersensitivity
• 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
• Fertile 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
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
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.	Week4, Week8, Week12
Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade	Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4.	Week4, Week8, Week12

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Botulinum toxin; Glabellar Lines; HU-045; Huons; HuonsBioPharma
• 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; Botulinum Toxins, Type A; incobotulinumtoxinA
• Other Study ID Numbers: HU-045_P2

Drug and device information, study documents

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