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Completed

NCT Number: NCT05298449

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

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Key information

Conditions

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung-Ang University

Seoul, Dongjak-gu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Percentage of participants whose glabellar lines at maximal frown are improved

    Time frame: Week4

    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.

Secondary outcomes

  1. Percentage of participants whose glabellar lines at maximal frown are improved

    Time frame: Week8, Week12

    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.

  2. Percentage of participants whose glabellar lines at resting are improved

    Time frame: Week4, Week8, Week12

    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.

  3. Subject's satisfaction rate after injection

    Time frame: Week4, Week8, Week12

    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.

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

    Time frame: Week4, Week8, Week12

    Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4.

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 28, 2022
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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