Chung-Ang University
Seoul, Dongjak-gu, South Korea
NCT Number: NCT05298449
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
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Notify Me19 year–65 year
All sexes
Interventional
Phase 2
Seoul, Dongjak-gu, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Week4
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
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, Week8, Week12
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
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
Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4.
Huons Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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