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| ID | Type | Description | Link |
|---|---|---|---|
| 06-2013-083 | Other Identifier | Seoul National University Bundang Hospital |
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| Name | Class |
|---|---|
| HumanTissueKorea Ltd. | UNKNOWN |
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- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial
Study Device: SkinPlus-Hyal® Comparator Device: Restylane®
- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane® | Active Comparator | Inject Restylane® on right or left nasolabial fold |
|
| SkinPlus-Hyal® | Experimental | Inject SkinPlus-Hyal® on right or left nasolabial fold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SkinPlus-Hyal® | Device | The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in WSRS of the test group and control group | The change in WSRS of the test group and control group from baseline at 24 weeks as assessed by the Investigator in charge of photographic assessment | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change in WSRS of the test and control groups | The change in WSRS of the test and control groups from baseline at 2, 8, 16, 24 weeks as assessed by the Investigator | baseline and 2, 8, 16, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects whose GAIS is 1 point or above | The percentage of subjects whose GAIS is 1 point or above at 2, 8, 16, 24 weeks after injection as assessed by the Investigator | 2, 8,16, 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chanyeong - Heo, Ph.D | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea | ||
| Seoul National University Hospital |
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| Restylane® | Device | The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner. |
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| Jongno-gu |
| Seoul |
| 110-744 |
| South Korea |