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
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Botulinum toxin type A(HG102)
|
Drug: Botulinum Toxin Type A Injection [HG102]
Single administration, Day 0, 20 units
Other Names:
|
| Active Comparator: Botulinum toxin type A(Botox®)
|
Drug: Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Responder rate of improvement in glabellar lines with Physician's rating line severity [Baseline to week 4]
Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection
Secondary Outcome Measures
- Responder rate of improvement in glabellar lines with Physician's rating line severity [Baseline to week 8, 12, 16]
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection
- Responder rate of improvement in glabellar lines with investigator's photo assessment [Baseline to week 4, 8, 12, 16]
Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection
- Responder rate of improvement in glabellar lines with investigator's photo assessment [Baseline to week 4, 8, 12, 16]
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
- 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 [Baseline to week 4, 8, 12, 16]
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection
- Participant-rated satisfaction after treatment [Baseline to week 4, 8, 12, 16]
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
Eligibility Criteria
Criteria
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
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Person with symptoms of facial palsy or blepharoptosis
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Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
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Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hugel
Investigators
- Principal Investigator: Ju Hee Lee, MD, PhD, Severance Hospital
- Principal Investigator: Si Hyung Lee, MD, PhD, Seoul National University Hospital
- Principal Investigator: Ik Joon Moon, MD, PhD, Asan Medical Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HG-102GL-PIII-01