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Following treatment with Radiesse, many patients mention an improvement in skin texture This observation is independent from the improvement observed on their facial shape. There is therefore a need to identify and quantify changes in skin parameters following treatment with Radiesse
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse (calcium hydroxylpatite) | Device | RADIESSE® injectable implant is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. RADIESSE injectable implant has a CaHA particle size range of 25-45 microns. RADIESSE is available in 1.5cc and 0.8cc pre-filled syringes. RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy). |
| Measure | Description | Time Frame |
|---|---|---|
| Hydration | Assessment of changes in hydration at Month 3, as assessed with the Courage and Khazaka system device, following the injection of RADIESSE, in perioral and marionette lines regions | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Hydration | Changes in hydration at Month 6, as assessed with the Courage and Khazaka system device; | Month 6 |
| Elasticity | Changes in elasticity at Month 3 and 6, as assessed with the Courage and Khazaka system device; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Nikolis, FRCSC | Erevna Innovations Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erevna Innovations Inc | Montreal | Quebec | H3R 3A1 | Canada |
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| Month 3 and 6 |
| pH | Changes in pH and quality of skin barrier function (TEWL - Trans Epidermal Water Loss) at Months 3 and 6, as assessed with the Courage and Khazaka sys | Month 3 and 6 |
| Skin texture | Changes in skin surface textural irregularities, smoothness, roughness, wrinkles and scaliness) at Months 3 and 6, as assessed with the Courage and Khazaka system. | Month 3 and 6 |
| Merz validated marionette scale | Changes in the aesthetic improvement using the Merz validated marionette scale at Months 3 and 6. This is a 5-point scale, where 0 = no lines and 4 = very severe lines. | Month 3 and 6 |
| Global Assessment Improvement Scale | Changes in the aesthetic appearance using the Global Assessment Improvement Scale (GAIS) using standardised 2D/3D photographs for patients and blinded physicians at Months 3 and 6; | Months 3 and 6 |
| Fitzpatrick Wrinkle Assessment Scale | 1. Changes in skin quality using the modified Fitzpatrick Wrinkle Assessment Scale (FWAS) and standardised 2D/3D photographs at Months 3 and 6. | Months 3 and 6 |