Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.

Official Title
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A Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Compare the Efficacy and Safety of HG102 Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

Conditions
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Glabellar Lines

Intervention / Treatment
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* Drug: Botulinum Toxin Type A Injection [HG102]
* Drug: Botulinum Toxin Type A Injection [Botox]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects that fit all of the criteria below were selected for this clinical trial. Male and female adults from 19 to 65 years old at the time of screening Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown Person who understands and can comply to the process and visiting schedule of this clinical study Person who gave spontaneous written consent to participate in this clinical study Exclusion Criteria: Subjects that fit any of the criteria below were excluded from this clinical trial. Person with infection, skin disease, or scar on forehead Person with symptoms of facial palsy or blepharoptosis Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.) Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication) Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer Other person who the investigator judges as inappropriate for the clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A(HG102)<br> | Drug: Botulinum Toxin Type A Injection [HG102]<br>* Single administration, Day 0, 20 units<br>* Other names: HG102;|
| Active Comparator: Botulinum toxin type A(Botox®)<br> | Drug: Botulinum Toxin Type A Injection [Botox]<br>* Single administration, Day 0, 20 units<br>* Other names: Botox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection | Baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection | Baseline to week 8, 12, 16 | 
| Responder rate of improvement in glabellar lines with investigator's photo assessment | Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 | 
| Responder rate of improvement in glabellar lines with investigator's photo assessment | Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 | 
| Independent photo evaluator-rated improvement rate of glabellar lines at rest |  | Baseline to week 4, 8, 12, 16 | 
| Responder rate of improvement in glabellar lines with Subject's improvement assessment | Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 | 
| Participant-rated satisfaction after treatment | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |