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The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lafullen15 | Experimental | PCL filler |
|
| Lafullen | Active Comparator | PCL filler |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lafullen15 | Device | Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator | The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome. | 12months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gyeongsoon Kim | Contact | +82-2-2157-9851 | gyeongsoon.kim@samyang.com |
| Name | Affiliation | Role |
|---|---|---|
| Jongho KIM, M.D.,Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
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A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study
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| Lafullen | Device | Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen). |
|