NCT05298449

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

March 16, 2022

Last Update Submit

July 2, 2023

Conditions

Glabellar Lines

Keywords

Glabellar LinesHU-045HuonsHuonsBioPharmaBotulinum toxin

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

  • Percentage of participants whose glabellar lines at resting are improved

    Week4, Week8, Week12

  • Subject's satisfaction rate after injection

    Week4, Week8, Week12

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

    Week4, Week8, Week12

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-045DRUG

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

Also known as: 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.

Also known as: IncobotulinumtoxinA
Xeomin® group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.)
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ang University

Seoul, Dongjak-gu, South Korea

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 28, 2022

Study Start

March 28, 2022

Primary Completion

November 7, 2022

Study Completion

April 25, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

KR(1)