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

Sponsor
Huons Biopharma
Study ID
NCT06205797
Phase
PHASE3
Status
Recruiting
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Conditions

  • Glabellar Lines

Eligibility Criteria

Sex
ALL
Age
19 Years - 65 Years
Healthy Volunteers
Accepted

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
  • 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

Study Details

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

Key Dates

Start date
Jun 20, 2024
Status verified
Oct 2024
Primary completion
Nov 30, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
312 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of participants whose glabellar lines at maximal frown are improved [ Time Frame: Week4 ]

Central Contacts