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This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group_VYC-25L | Experimental | VYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable |
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| Control Group_No treatment then VYC-25L | Other | No treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid Injectable Gel | Device | Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS) | Month 3 | |
| Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS |
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Inclusion Criteria:
-Has chin retrusion.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smita Chawla | Allergan, plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet medical Solferino | Paris | 75007 | France | |||
| Centre de Chirurgie Esthetique |
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| Label | URL |
|---|---|
| More Information | View source |
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| Month 3 |
| Toulouse |
| 31000 |
| France |
| Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann | Bochum | 44803 | Germany |
| Dermatolgie Köln am Rhein | Cologne | 50996 | Germany |
| Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH | Darmstadt | 64283 | Germany |
| Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie | Kassel | 34121 | Germany |
| Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster | Munich | 80333 | Germany |
| Dermatogische Privatpraxis CentroDerm GmbH | Wuppertal | 42287 | Germany |
| Kliniek Dokter Frodo Gaymans | Amsterdam | 1075 | Netherlands |
| Joost Kroon Cosmetische Kliniek | Amsterdam | 1077 | Netherlands |