To Evaluate HU-045 With Moderate to Severe Glabellar Lines
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
Adults aged 19 to 65 years, inclusive, as of the date of written informed consent.
Subjects who have a glabellar line severity score of 2 (moderate) or greater, as assessed by the investigator, when maximizing frown (frowning) at the screening and randomization visits.
Subjects who are able to comply with the visit schedule according to the clinical trial procedures.
Subjects who signed voluntarily in informed consent form and fully understood about this clinical trial.
Disqualifiers
Subjects with a known history of allergy or hypersensitivity to the investigational product or any of its components (or ingredients).
Subjects with a systemic neuromuscular junction disorder that may affect neuromuscular function. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
Subjects with an infection or skin disease at the treatment injection sites.
Subjects with structural or physical facial features (or conditions) that may hinder or prevent improvement (facial nerve palsy or eyebrow/eyelid ptosis, marked facial asymmetry etc.)
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. 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
390 Participants
are divided into 2 treatment groupsGroup A: HU-045Experimental treatment 1 intervention
Group B: Xeomin®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Whose Glabellar Lines at Maximal Frown Are Improved as Assessed by the Investigator
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or3=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 as Assessed by the Investigator
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
Week 8, Week 12, and Week 162
Percentage of Participants Whose Glabellar Lines at Rest Are Improved as Assessed by the Investigator
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at rest; 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
Week 4, Week 8, Week 12, and Week 163
Percentage of Participants Whose Glabellar Lines at Maximal Frown Are Improved Based on Independent Evaluators' Photographic Assessment
Independent evaluators will assess participant's glabellar lines using photographs taken at rest with Facial Wrinkle Scale (FWS); 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
Week 4, Week 8, Week 12, and Week 164
Percentage of Participants Whose Glabellar Lines at Rest Are Improved Based on Independent Evaluators' Photographic Assessment
Independent evaluators will assess participant's glabellar lines using photographs taken at rest with Facial Wrinkle Scale (FWS); 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
Week 4, Week 8, Week 12, and Week 16Sponsors and contacts
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Source ClinicalTrials.gov