Clinical trial NCT05298449: Phase 2 of HU-045 in Glabellar Lines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Lines
Keywords: Glabellar Lines
HU-045
Huons
HuonsBioPharma
Botulinum toxin
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of participants whose glabellar lines at maximal frown are improved
timeFrame: Week4
Secondary outcomes:
measure: Percentage of participants whose glabellar lines at maximal frown are improved
timeFrame: Week8, Week12
measure: Percentage of participants whose glabellar lines at resting are improved
timeFrame: Week4, Week8, Week12
measure: Subject's satisfaction rate after injection
timeFrame: Week4, Week8, Week12
measure: Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade
timeFrame: Week4, Week8, Week12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University
state: Dongjak-gu
Study officials:
References: