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
312
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® 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
Kangbuk Samsung Hospital
Seoul, South Korea
RECRUITINGPercentage 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, Week16
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, Week16
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; (1 = very unsatisfied, 2 = un satisfied, 3 = slightly dissatisfied, 4 = average, 5 = slightly satisfied, 6 = Satisfaction, 7 = very satisfied
Time frame: Week4, Week8, Week12, Week16
Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade
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Subjects will assess their glabellar Lines with a 9 point scale from -4 to +4;(+4 = 100% improvement, +3 = 75% improvement, +2 = 50% improvement, +1 = 25% improvement, 0 = no change, -1 = 25% worse, -2 = 50% worse, -3 = 75% worse, -4 = 100% worse
Time frame: Week4, Week8, Week12, Week16