Overview
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.
Eligibility
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