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This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermalax Implant Plus | Experimental | Subject injected in the nasolabial folds of one side of the face in the initial treatment period. |
|
| Restylane Sub-Q | Active Comparator | Subject injected in the nasolabial folds of one side of the face in the initial treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermalax Implant Plus | Device | Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group | Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos. | baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group | Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos. | baseline, at week 2~24 |
| Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved |
| Measure | Description | Time Frame |
|---|---|---|
| Safty evaluation | adverse events, laboratory test, physical examination | for 24weeks |
Inclusion Criteria:
Male or female subjects no younger than 30 and no more than 75 years of age.
Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)
*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.
Subjects who have symmetric nasolabial folds.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beom Joon Kim, MD | Chung-Ang University Hospital | Principal Investigator |
| Jong Hoon Lee, MD | Eulji General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ang University Hospital | Seoul | South Korea | ||||
| Eulji General Hospital |
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| Restylane Sub-Q | Device | Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period. |
|
Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved at week2, week 8, week 12, week 16, week 24 evaluated by investigator at site |
| at week 2~24 |
| 100 mm visual analogue scale (VAS) scores evaluation | 100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices | week 0 |
| Seoul |
| South Korea |