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This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP0116 | Experimental |
| |
| FDA Approved Device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP0116 | Device | GP0116 is an injectable, sterile, transparent product. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate non-inferiority of GP0116 versus a comparator control | To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS). | At 3 months after Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (Site#8074) | Santa Monica | California | 90404 | United States | ||
| Galderma Investigational Site (Site#8478) |
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| Active Comparator: FDA approved dermal filler device (RHA 3) |
| Device |
FDA approved dermal filler device (RHA 3) |
|
| Vista |
| California |
| 92083 |
| United States |
| Galderma Investigational Site (Site#8680) | Westport | Connecticut | 06880 | United States |
| Galderma Investigational Site (Site#8479) | Bradenton | Florida | 34209 | United States |
| Galderma Investigational Site (Site#7030) | Coral Gables | Florida | 33134 | United States |
| Galderma Investigational Site (Site#8284) | Coral Gables | Florida | 33146 | United States |
| Galderma Investigational Site (Site#8126) | West Palm Beach | Florida | 33401 | United States |
| Galderma Investigational Site (Site#7042) | Atlanta | Georgia | 30331 | United States |
| Galderma Investigational Site (Site#8580) | New Orleans | Louisiana | 70130 | United States |
| Galderma Investigational Site (Site#8481) | Chestnut Hill | Massachusetts | 02467 | United States |
| Galderma Investigational Site (Site#8631) | Birmingham | Michigan | 48009 | United States |
| Galderma Investigational Site (Site#8658) | New York | New York | 10021 | United States |
| Galderma Investigational Site (Site#8482) | Chapel Hill | North Carolina | 27517 | United States |
| Galderma Investigational Site (Site#8648) | Wilmington | North Carolina | 28405 | United States |
| Galderma Investigational Site (Site#8783) | Cincinnati | Ohio | 45236 | United States |
| Galderma Investigational Site (Site#8496) | Nashville | Tennessee | 37203 | United States |
| Galderma Investigational Site (Site#8662) | Spring | Texas | 77388 | United States |
| Galderma Investigational Site (Site#7047) | Arlington | Virginia | 22209 | United States |
| Galderma Investigational Site (Site#8784) | San Juan | 00917 | Puerto Rico |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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