Phase 2 of HU-045 in Glabellar Lines

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huons Co., Ltd.
• Treatments: Botulinum Toxins, Type A; incobotulinumtoxinA

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.