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The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds
This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.
Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuramis® Deep Lidocaine | Experimental | Neuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
|
| Restylane® PERLANE-L | Active Comparator | Restylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuramis® Deep Lidocaine | Device | HA filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs | from baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Wrinkle Severity Rating Scale as evaluated by an investigator | from baseline to 8, 16, 24 weeks | |
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator | from baseline to 8, 16, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hoon Kang | Catholic University St. Paul Hospital | Principal Investigator |
| BeomJoon Kim | Chung-Ang Univ. Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University St. Paul Hospital | Seoul | Dongdaemun-gu | 130-709 | South Korea | ||
| Chung-Ang Univ. Medical Center |
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| Restylane® PERLANE-L |
| Device |
HA filler |
|
| Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs | from baseline to 8, 16 weeks |
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters | from baseline to 8, 16, 24 weeks |
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator | 8, 16, 24 weeks after the injection |
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject | 8, 16, 24 weeks after the injection |
| Visual Analogue Scale as evaluated by a subject | at 15, 30, 45, 60 minutes after the injection |
| Vital signs, physical examination, laboratory tests and adverse events | from baseline to 24 weeks |
| Seoul |
| Dongjak-gu |
| 156-755 |
| South Korea |