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The objective of this Pilot Study is to verify the safety and efficacy of DMSB01 in the temporary improvement of Crow's Feet Lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMSB01 | Experimental | mPEG-PLA |
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| RejuranĀ® | Active Comparator | PN |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMSB01 | Device | Apply a maximum of 1.0 ml for each side of the Crow's Feet Lines using both the test device (DMSB01) and the control device (RejuranĀ®). |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in CFGS at 4, 8, 12 weeks after the last application of the clinical trial medical device compared to the baseline evaluated by Investigator and independent evaluators | The Crow's Feet Grading Scale is a 5-point scale with 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe and 4 = Extreme. 0 is the best outcome while 4 is the worst outcome. The higher scores mean a worse outcome. | 4, 8, 12 weeks |
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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, Subject and Evaluator blinded, Matched pairs, Pilot Study
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| RejuranĀ® | Device | Apply a maximum of 1.0 ml for each side of the Crow's Feet Lines using both the test device (DMSB01) and the control device (RejuranĀ®). |
|