Phase 2 of HU-045 in Glabellar Lines

NCT ID: NCT05298449

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-04-25

Brief 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

Conditions

Glabellar Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HU-045 group

HU-045 Injection group will receive intramuscular injection of HU-045 to a total of 5 glabellar line sites 4 U/0.1ml each.

HU-045 will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered.

Group Type: EXPERIMENTAL

HU-045

Intervention Type: DRUG

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

Xeomin® group

Xeomin® Injection group will receive intramuscular injection of Xeomin® to a total of 5 glabellar line sites 4 U/0.1ml each.

Xeomin® will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered.

Group Type: ACTIVE_COMPARATOR

Xeomin®

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

IncobotulinumtoxinA; IncobotulinumtoxinA

Eligibility Criteria

Inclusion Criteria

• 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.)
• 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
• Subject who has been treated with any botulinum toxin drug within 6 months
• Subject who takes skeletal muscle relaxants,
• Subject who takes a anticoagulant, antiplatelet, NSAIDs, Vitamin E of over 1,000IU/day (except for low dose aspirin)
• From screening,
• Subject who have positive results of HIV, Syphilis, HBV, HCV
• Drug Hypersensitivity
• 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
• Fertile 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huons Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung-Ang University

Seoul, Dongjak-gu, South Korea

Countries

South Korea

Other Identifiers

HU-045_P2

Identifier Type: -

Identifier Source: org_study_id