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This is a phase IV prospective, multicentre, single cohort, open-label clinical trial evaluating the efficacy and safety of Poly-L-lactic acid (Sculptra® Aesthetic) for the treatment of contour deformities of the buttocks region
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-lactic acid (Sculptra® Aesthetic) | Device | Sculptra® Aesthetic is a commercially available product that is licensed for sale in Canada. It is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA), a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra® Aesthetic is suitable for increasing the volume of depressed areas, particularly to correct skin depressions, such as in skin creases, wrinkles, folds, scars and for skin aging. Sculptra® Aesthetic is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy). The safety and efficacy of Sculptra® Aesthetic has been investigated in the literature and is generally considered safe and effective. PLLA has been used successfully to reverse HIV-associated lipoatrophy as well as to rejuvenate the face, neck, décolletage, hands, abdomen and gluteal regions. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects to achieve a one-point increase or higher since Baseline, on the Global Aesthetic Improvement Scale (GAIS) at Visit 6 | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events (AEs) at all study visits (Visits 0-6). The incidence, seriousness, severity and relationship with the medical device of AEs reported will be evaluated. | All visits, Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin hydration as measured by the corneometer | The Corneometer® CM 825 will be used to measure the skin's hydration, in the center of each four buttock quadrant, at all visits. | All Visits; Baseline to month 6 |
| Corporeal contour as measured by the VisioScan |
Inclusion Criteria:
Exclusion Criteria:
Female gender.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erevna Innovations Inc | Westmount | Quebec | H3R 3A1 | Canada |
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Evaluation of corporeal contour will be performed at all visits using The Visioscan® VC 98 to identify select, major surface irregularities and/or textural depressions caused by skin sagging (often mistaken for "cellulite").
| All Visits; Baseline to month 6 |
| Skin elasticity as measured by the cutometer | Evaluation of corporeal contour and skin parameters, using The Cutometer® Dual Multi-Probe Adapter (MPA) 580 to measure skin's elasticity, at all visits. | All Visits; Baseline to month 6 |
| cellulite severity as evaluated by the Nürnberger-Müller Scale for Cellulite | Evaluations of the blinded reviewer's Nürnberger-Müller Scale for Cellulite between Baseline (Visit 0/1) and Follow up visits (Visits 4 to 6). The Nurnberger-Muller Scale classifies cellulite into four categories: Stage Zero No dimpling is seen on the skin when you are standing naked in front of the mirror. When the skin is pinched no orange peel effect is seen. Stage One No dimpling is seen on the skin when you are standing, but when you pinch your skin you have bumps and lumps. Stage two You can see dimpling or the orange peel appearance when standing naked in front of the mirror, but not when lie down. Stage three You can see dimpling both when you are standing and lying down. | Baseline and month 3; Baseline and month 6 |
| Evaluations of patient satisfaction using the Patient Satisfaction Questionnaire at all visits | The Patient Satisfaction Questionnaire is a 5-point likert scale, including: Very dissatisfied; Dissatisfied; Slightly satisfied; Satisfied; Very satisfied. | All Visits; Baseline to month 6 |
| Evaluations of the investigator assessed GAIS scale at all visits (0-6). | The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "worse," "no change," "improved," "much improved," and "very much improved." | Baseline to Month 6 |