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This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Shaype | Experimental | Restylane Shaype is approved and commercially available for use in Canada and is manufactured by Q-Med AB, part of the Galderma Group. The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator. |
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| Juvederm Volux | Active Comparator | Juvéderm Volux is approved and commercially available for use in Canada and is manufactured by Allergan Aesthetics, an Abbvie company. The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Shaype | Device | Half (50%) of study participants will receive Restylane Shaype for the treatment of mild to severe chin retrusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant group differences in the average three-dimensional volumetric increase since baseline | As assessed by the Canfield Vectra XT system. | Baseline to Week 2, Week 4, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale) | The Galderma Chin Retrusion Scale is a 4 point Likert Scale used to assess chin retrusion ranging from "no retrusion" (grade 0) to "severe retrusion" (grade 3) | Baseline to Week 2, Week 4, Week 12, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Nikolis, MD | Erevna Innovations Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erevna Innovations Inc. | Montreal | Quebec | H3R3A1 | Canada |
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| Juvéderm Volux | Device | Half (50%) of study participants will receive Juvéderm Volux for the treatment of mild to severe chin retrusion |
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| Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale) |
The Global Aesthetic Improvement Scale is a 5 point Likert Scale in which the blinded investigator can assess change in chin retrusion following aesthetic treatment. The grading scale ranges from "worse" (grade -1) to "very much improved" (grade 3) |
| Baseline to Week 2, Week 4, Week 12, Week 24 |
| Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues) | This will be done by means of measurement of the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues. | Baseline to Week 2, Week 4, Week 12, Week 24 |