Last updated: January 11, 2024
Sponsor: Hugel
Overall Status: Active - Recruiting
Phase
3
Condition
N/ATreatment
Botulinum Toxin Type A Injection [Botox]
Botulinum Toxin Type A Injection [HG102]
Clinical Study ID
NCT05801146
HG-102GL-PIII-01
Ages 19-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 2-3according to Physician's Rating Line Severity at maximum frown
- Person who understands and can comply to the process and visiting schedule ofthis clinical study
- Person who gave spontaneous written consent to participate in this clinical study
Exclusion
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 inthe investigational product (botulinum toxin formula, serum albumin, etc.)
- Person who were administered with similar medication within 12 weeks (botulinumtoxin type A medication) or 16 weeks (botulinum toxin type B medication)
- Pregnant and breast-feeding women, men and women in the childbearing age who areplanning to get pregnant during the clinical study period, or do not agree to thesuitable contraceptive methods
- Person who participated in another clinical trial, or were given medication forother 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
Study Design
Total Participants: 272
Treatment Group(s): 2
Primary Treatment: Botulinum Toxin Type A Injection [Botox]
Phase: 3
Study Start date:
January 04, 2024
Estimated Completion Date:
October 31, 2025
Connect with a study center
Chung-Ang University Hopspital
Seoul, Dongjak-gu
Korea, Republic ofSite Not Available
Hugel
Seoul,
Korea, Republic ofActive - Recruiting

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