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A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial.
This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YYD701-2 | Experimental | YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
|
| Restylane Perlane Lidocaine | Active Comparator | Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YYD701-2 | Device | HA Filler |
| |
| Restylane Perlane Lidocaine |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 2, 8, 16 weeks |
| The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang Univ. Medical Center | Seoul | South Korea | ||||
| Konkuk University Medical Center |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
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| Device |
HA Filler |
|
Score of WSRS assessed by the investigator |
| from baseline to 2, 8, 16, 24 weeks |
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator | Score of GAIS assessed by the investigator | 2, 8, 16, 24 weeks after week 0 (injection date) |
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject | Score of GAIS assessed by subject | 2, 8, 16, 24 weeks after week 0 (injection date) |
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 2, 8, 16, 24 weeks |
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator | Score of WSRS assessed by the investigator | from baseline to 2, 8, 16, 24 weeks |
| Visual Analogue Scale as evaluated by a subject | Score of VAS assessed by subject | week 0 (injection date) |
| Seoul |
| South Korea |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |