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RECRUITING

NCT06205797

PHASE3

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

Sponsor: Huons Biopharma

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

312

Start Date

2024-06-20

Completion Date

2025-03-31

Last Updated

2024-10-03

Healthy Volunteers

Yes

Conditions

Glabellar Lines

Interventions

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

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. Other Names: IncobotulinumtoxinA

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.

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea