To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)

Glabellar Lines Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or Severe Glabellar Lines

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205797
• Other study ID #: HU-045_P3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 15, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: January 2024
• Source: Huons Biopharma
• Contact: SUNGGUK CHO
• Phone: +82-02-854-4700
• Email: sgcho[@]huons.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: July 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• History of facial nerve palsy or eyebrow/eyelid ptosis

• History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas

• History of malignant tumor within 5 years (except for basal cell carcinoma

• Any disease and condition that, in the view of the investigator, would interfere with study participation

• History of alcohol or drug addiction

• Subject who has been treated with any botulinum toxin drug within 6 months

• Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening

• Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)

• A person who has received a retinoid series of medications during the following period as of the time of screening

• Subjects who have hypersensitivity reaction to investigational drug or local anesthetics

• History of Anaphylaxis or severe combined allergy disease

• Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out

• Pregnant and lactating women F- ertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.

• Participant who has been treated with any investigational drug within 30 days from screening

• Subject who are not eligible for this study based on investigator's judgement.

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• HU-045
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®
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huons Biopharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week4
Secondary	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.	Week8, Week12, Week16
Secondary	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.	Week4, Week8, Week12, Week16
Secondary	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	Week4, Week8, Week12, Week16
Secondary	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	Week4, Week8, Week12, Week16