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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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).
Erevna Innovations Inc
Montreal, Quebec, Canada
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
Time frame: Month 3
Hydration
Changes in hydration at Month 6, as assessed with the Courage and Khazaka system device;
Time frame: Month 6
Elasticity
Changes in elasticity at Month 3 and 6, as assessed with the Courage and Khazaka system device;
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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;
Time frame: Months 3 and 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Months 3 and 6