Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A (INI101) | Experimental |
| |
| Botulinum toxin type A (BOTOX®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A Injection [INI101] | Drug | Single administration, Day 0, 20 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment | 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. | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment | 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. | Baseline to week 8, 12, 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INIBIO Co., Ltd. | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Botulinum Toxin Type A Injection [Botox] | Drug | Single administration, Day 0, 20 units |
|
| Improvement rate of glabellar lines at rest according to the investigator's on-site assessment | 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. | Baseline to week 4, 8, 12, 16 |
| Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment | 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. | Baseline to week 4, 8, 12, 16 |
| Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment | 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. | Baseline to week 4, 8, 12, 16 |
| Improvement rate of glabellar lines as assessed by the subject | Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline. | Baseline to week 4, 8, 12, 16 |
| Subject's satisfaction | 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. | Baseline to week 4, 8, 12, 16 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |