Clinical trial NCT06205797: To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: Huons Biopharma
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 312
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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:

* 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.

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, Week16
measure: Percentage of participants whose glabellar lines at resting are improved
timeFrame: Week4, Week8, Week12, Week16
measure: Subject's satisfaction rate after injection
timeFrame: Week4, Week8, Week12, Week16
measure: Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade
timeFrame: Week4, Week8, Week12, Week16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References: