Status:
COMPLETED
Phase 2 of HU-045 in Glabellar Lines
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Glabellar Lines
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
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 Li...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05298449
Start Date
March 28 2022
End Date
April 25 2023
Last Update
July 5 2023
Active Locations (1)
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1
Chung-Ang University
Seoul, Dongjak-gu, South Korea