Glabellar Lines
Conditions
Brief summary
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
Interventions
DRUGBotulinum Toxin Type A Injection [INI101]
Single administration, Day 0, 20 units
Single administration, Day 0, 20 units
Sponsors
INIBIO Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult male or female participants aged between 19 and 65 years old. 2. Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization. 3. Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them. 4. Participants who can understand and comply with the procedures and visit schedules of the study.
Exclusion criteria
1. Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.) 2. History of blepharoplegia or ptosis 3. Prominent facial asymmetry 4. Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands 5. Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening 6. Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin \[325 mg/day or less\] administered for antithrombotic purposes is acceptable) 7. Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device 8. Participants deemed ineligible for this study for other reasons based on the investigator's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment | Baseline to week 4 | Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment | Baseline to week 8, 12, 16 | Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. |
| Improvement rate of glabellar lines at rest according to the investigator's on-site assessment | Baseline to week 4, 8, 12, 16 | Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. |
| Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment | Baseline to week 4, 8, 12, 16 | Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken. |
| Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment | Baseline to week 4, 8, 12, 16 | Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken. |
| Improvement rate of glabellar lines as assessed by the subject | Baseline to week 4, 8, 12, 16 | Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline. |
| Subject's satisfaction | Baseline to week 4, 8, 12, 16 | Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration. |
Countries
South Korea
Outcome results
None listed