Phase 2 of HU-045 in Glabellar Lines

Phase 2

Completed

• Conditions: Glabellar Lines
• Interventions: Drug: Xeomin®; Drug: HU-045

• Registration Number: NCT05298449
• Lead Sponsor: Huons Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Study Start: 2022-03-28
• Study First Posted: 2022-03-28
• Primary Completion: 2022-11-07
• Study Completion: 2023-04-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xeomin® group	Xeomin®	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.
HU-045 group	HU-045	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants whose glabellar lines at maximal frown are improved	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants whose glabellar lines at maximal frown are improved	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.
Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade	Week4, Week8, Week12	Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4.
Percentage of participants whose glabellar lines at resting are improved	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.
Subject's satisfaction rate after injection	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.

Trial Locations

Locations (1)

Chung-Ang University; 🇰🇷 Seoul, Dongjak-gu, Korea, Republic of