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

NCT06205797 | Recruiting Phase 3

• 1 other identifier: HU-045_P3
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Percentage of participants whose glabellar lines at maximal frown are improved

  Week8, Week12, Week16

• Percentage of participants whose glabellar lines at resting are improved

  Week4, Week8, Week12, Week16

• Subject's satisfaction rate after injection

  Week4, Week8, Week12, Week16

• Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade

  Week4, Week8, Week12, Week16

Study Arms (2)

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

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

HU-045 group

Xeomin® DRUG

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

Xeomin® group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years to 65 Years(Adult, Older Adult)
• (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Biopharma: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA

Central Study Contacts

Saeroarum Han

CONTACT

82-70-7492-6032; saeroarum@huonsbiopharma.com

Jiwon Kim

CONTACT

82-70-7492-6074; jw.kim@huonsbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: June 20, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)