Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines
NCT ID: NCT05801146
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
272 participants
INTERVENTIONAL
2024-01-04
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum toxin type A(HG102)
Botulinum Toxin Type A Injection [HG102]
Single administration, Day 0, 20 units
Botulinum toxin type A(Botox®)
Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units
Interventions
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Botulinum Toxin Type A Injection [HG102]
Single administration, Day 0, 20 units
Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male and female adults from 19 to 65 years old at the time of screening
2. Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown
3. Person who understands and can comply to the process and visiting schedule of this clinical study
4. Person who gave spontaneous written consent to participate in this clinical study
Exclusion Criteria
1. Person with infection, skin disease, or scar on forehead
2. Person with symptoms of facial palsy or blepharoptosis
3. Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
4. Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
5. 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
6. 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
7. Other person who the investigator judges as inappropriate for the clinical trial
19 Years
65 Years
ALL
No
Sponsors
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Hugel
INDUSTRY
Responsible Party
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Locations
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Hugel
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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ChoLong Park
Role: primary
Other Identifiers
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HG-102GL-PIII-01
Identifier Type: -
Identifier Source: org_study_id
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