Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. 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 subeject diary and follow up visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuramis | Experimental |
| |
| Restylane® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HA filler | Device | The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| WSRS | The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment | 24 weeks after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS | The change between baseline and 2, 8, 16, 24 week WSRS evaluated by the investigator in charge of photographic assessment | 2, 8, 16, 24 weeks after the injection |
| WSRS | The change between baseline and 2, 8, 16 week WSRS evaluated by the investigator in charge of live assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chan Yeong Heo | Seoul National University Bundang Hospital | Principal Investigator |
| Saik Bang | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnam | 135-710 | South Korea | ||
| Seoul National University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26618119 | Derived | Pak C, Park J, Hong J, Jeong J, Bang S, Heo CY. A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds. Arch Plast Surg. 2015 Nov;42(6):721-8. doi: 10.5999/aps.2015.42.6.721. Epub 2015 Nov 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2, 8, 16 weeks after the injection |
| GAIS | The rate of subjects whose GAIS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks from the injection | 2, 8, 16, 24 weeks after the injection |
| GAIS | The rate of subjects whose GAIS, evaluated by the subjects him/herselves, is 1 point or above after 2, 8, 16, 24 weeks from the injection | 2, 8, 16, 24 weeks after the injection |
| WSRS | The rate of subjects whose change of WSRS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks of the injection | 2, 8, 16, 24 weeks after the injection |
| WSRS | The rate of subjects whose change of WSRS, evaluated by the investigator in charge of photographic assessment, is 1 pointe or above after 2, 8, 16, 24 weeks of the injection | 2, 8, 16, 24 weeks after the injection |
| Number of adverse events in subjects | Adverse events occured after informed consent, Adverse drug events, Serious adverse events, lab test, physical examination, vital signs | Up to 24 weeks |
| Seongnam |
| Gyunggi |
| 463-707 |
| South Korea |