To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
ConditionGlabellar Lines
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-65
SponsorHuons Biopharma
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
19 Years to 65 Years(Adult, Older Adult)
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.
Disqualifiers
Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
History of bleeding disorder
Infection, dermatological condition or scar at the treatment injection sites
Subject who has marked facial asymmetry
Trial design
Design model
Parallel
Treatments tested in this trial
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 Other Names: IncobotulinumtoxinA
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. Other Names: IncobotulinumtoxinA
Treatment groups
312 Participants
are divided into 2 treatment groupsGroup A: HU-045 groupExperimental treatment 1 intervention
Group B: Xeomin® groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Week4Secondary outcomes
1
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, Week162
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, Week163
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, Week164
Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade
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, Week16Sponsors and contacts
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Source ClinicalTrials.gov