Efficacy and Safety of Poly-L-lactic Acid

Lead sponsor

Erevna Innovations Inc. is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Interventions

• DevicePoly-L-lactic acid (Sculptra® Aesthetic)

  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.

Primary outcomes

1. Percentage of subjects to achieve a one-point increase or higher since Baseline, on the Global Aesthetic Improvement Scale (GAIS) at Visit 6

   Time frame: Month 6

Secondary outcomes

1. 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.

   Time frame: All visits, Baseline to Month 6

Other outcomes

1. 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.

   Time frame: All Visits; Baseline to month 6

2. Corporeal contour as measured by the VisioScan

   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").

   Time frame: All Visits; Baseline to month 6

3. 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.

   Time frame: All Visits; Baseline to month 6

4. 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.

   Time frame: Baseline and month 3; Baseline and month 6

5. 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.

   Time frame: All Visits; Baseline to month 6

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."

   Time frame: Baseline to Month 6

Individual participant data

Plan to share: No