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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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
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.
Chung-Ang University
Seoul, Dongjak-gu, South Korea
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.
Time frame: Week4
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.
Time frame: Week8, Week12
Percentage of participants whose glabellar lines at resting are improved
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.
Time frame: Week4, Week8, Week12
Subject's satisfaction rate after injection
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.
Time frame: Week4, Week8, Week12
Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade
Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4.
Time frame: Week4, Week8, Week12
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