Phase 2 of HU-045 in Glabellar Lines
- Sponsor
- Huons Co., Ltd.
- Study ID
- NCT05298449
- Phase
- PHASE2
- Status
- Completed
Conditions
- Glabellar Lines
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- HU-045 — DRUGHU-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
- Xeomin® — DRUGXeomin® 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.
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
- Mar 28, 2022
- Status verified
- Jul 2023
- Primary completion
- Nov 7, 2022
- Completion
- Apr 25, 2023
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: HU-045 groupHU-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® groupXeomin® 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 ]