To Compare the Safety and Efficacy of HG-102 With Botox® in the Improvement of Moderate to Severe Glabellar Lines.

Study Overview
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Brief Summary
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To compare the safety and efficacy of HG-102 with Botox® in the improvement of moderate to severe glabellar lines.

Detailed Description
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Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of HG-102 compared to Botox® in subjects with moderate to severe Glabellar Lines

Official Title
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Double-blinded, Randomized, Active Control, Single Center-designed, Phase I Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of HG-102 Compared to 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 [Botox]
* Drug: Botulinum toxin type A injection [HG-102]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 19 and 65 at screening visit. Patients who voluntarily sign the informed consent. Patients who can comply with the study procedures and visit schedule. Exclusion Criteria: Patients with infection, skin disorders, or scars at the glabellar region. Patients with facial palsy or the symptoms of blepharoptosis. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception. Subjects who are not eligible for this study based on investigator's judgement.

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 |
| --- | --- |
| Active Comparator: Botulinum toxin type A(Botox®)<br>Botulinum toxin type A(Botox®) 100 Unit | Drug: Botulinum Toxin Type A Injection [Botox]<br>* Single administration, Day 0, 20 units<br>* Other names: Botox®;|
| Experimental: Botulinum toxin type A(HG-102)<br>Botulinum toxin type A(HG-102) 100 Unit | Drug: Botulinum toxin type A injection [HG-102]<br>* Single administration, Day 0, 20 units<br>* Other names: HG-102;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event and adverse drug reaction incidence rates |  | Baseline to week 16 | 
| Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel |  | 16 weeks (during the clinical trial) | 

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 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 maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 | 
| Responder rate of improvement in glabellar lines with Physician's rating line severity | 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 | 
| Changes in grade by physician's rating line severity for glabellar lines | Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline | 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 | 
| Subject's satisfaction rate | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 | 
| The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) | The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain)) | Baseline |