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The study is to verify that Dermalax (Deep) is not inferior to the reference device, Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subject diary and follow up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermalax(Deep) | Experimental | subject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period |
|
| Restylane | Active Comparator | Subject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermalax(Deep) | Device | Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale(WSRS) evaluation | Wrinkle Severity Rating Scale(WSRS) evaluation at week 24 | at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group | Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 36, week 48 by independent evaluator | at week 8~ 48 |
| The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group |
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Inclusion Criteria:
Male or female subjects no younger than 30 and no more than 65 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.
Subjects who agreed to discontinue the use of any dermatological procedure or therapy, including facial wrinkle reduction procedures.
Subjects with the ability to understand and follow the instructions and who are committed to availability for the entire study period.
Subjects who have voluntarily decided to participate in this study and who have signed the informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beom Joon Kim, PhD | Chung-Ang University Hospital | Principal Investigator |
| Jong Hoon Lee, PhD | 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 | Device | Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period |
|
Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 24, week 36, week 48 by investigator |
| at week 8~ 48 |
| The mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group | Global Aesthetic Improvement Scale(GAIS) evaluation at week8, week 16, week 36, week 48 by investigator | at week 8~48 |
| Mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group | Global Aesthetic Improvement Scale(GAIS) scores evaluation at week 8, 16, 24, 36, 48 by subjects | at week 8~48 |
| The proportion of subjects whose WSRS scores decreased at least 1 level | the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by independent evaluator. | at week 0~48 |
| The proportion of subjects whose WSRS scores decreased at least 1 level | the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by investigator | at week 0~48 |
| Seoul |
| South Korea |