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| Name | Class |
|---|---|
| HansBiomed Co.,Ltd. | INDUSTRY |
The objective of this clinical test is to verify the safety and efficacy of MINTLIFT®, used for the purpose of improving the appearance of the nasolabial fold on both sides of the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lift thread | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINTLIFT® | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by an independent evaluator | The percentage of the subjects within the test group who demonstrated wrinkle improvement to -1 or below in WSRS in the 12th week following the application of the device in comparison to the condition prior to the application (12th week- prior to application) as determined by an independent evaluator | 12th week of the application of the test device |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by an independent evaluator | in the 4th, 8th and 24th week following the application of the device | |
| The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by the investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beom Joon KIM, MD, PhD | Contact | +82-2-6299-1525 | beomjoon74@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Beom Joon KIM, MD, PhD | Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
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| in the 4th, 8th, 12th and 24th week following the application of the device |
| The average of the differences between the baseline and the WSRS evaluated by the independent evaluator | in the 4th, 8th, 12th and 24th week following the application of the test device |
| The average of the differences between the baseline and the WSRS evaluated by the subject | in the 4th, 8th, 12th and 24th week following the application of the test device |
| The average value of Global Aesthetic Improvement Scale (GAIS) scores as determined by the investigator and the distribution of scores | in the 12th and 24th week following the application of the test device |
| The average value of GAIS scores as determined by the subject and the distribution of scores | in the 12th and 24th week following the application of the test device |