BACKGROUND: Correction of cheek wrinkles using poly-l-lactic acid (PLLA-SCA) was demonstrated in a 12-month study. OBJECTIVE: This analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data. METHODS: Subjects received PLLA-SCA (reconstituted in 8 mL of sterile water + 1 mL of 2% lidocaine) in both cheeks or no treatment (control). Assessments included the Galderma Cheek Wrinkle Scale (GCWS), aesthetic improvement, and 3D photography. In subjects with severe GCWS at baseline, Canfield software analyzed 3D images for change from baseline in midface volume projection and volume change of both cheeks at Month 9. RESULTS: The primary study showed a statistically significant higher at-rest GCWS responder rate at Month 12 for PLLA-SCA, 71.6%, versus control, 26.1% (p < .0001). In this Month 9 analysis, mean midface volume projection demonstrated a positive volume shift for PLLA-SCA (left: 0.45 mm; right: 0.34 mm; n = 46) versus control (left: 0.25 mm; right: −0.01 mm; n = 21). Midface volume and max projection changes for PLLA-SCA were +4.88 mL/+1.62 mm (left), +2.84 mL/+1.12 mm (right) versus +0.26 mL/+0.34 mm (left), +0.68 mL/+0.37 mm (right) for control. CONCLUSION: Poly-l-lactic acid-treatment of subjects with severe GCWS had a clinically meaningful lifting effect in both cheeks (positive volume shift, positive volume change, and max projection) in the midface. Clinical trial registry number: NCT04124692.

This study evaluated the thermal properties, crystallinity, particle size, morphology, and in vivo local inflammation and persistence of two poly-L-lactic acid (PLLA) injectable implants, Sculptra^® (PLLA-SCA) and GANA V^® (PLLA-GA). PLLA-SCA and PLLA-GA underwent differential scanning calorimetry and X-ray powder diffraction to evaluate their thermal properties and degree of crystallinity. X-ray powder diffraction spectra displayed a sharper, more intense peak for PLLA-GA than PLLA-SCA, with smaller peaks on either side of the main peak of PLLA-GA but not PLLA-SCA. Differential scanning calorimetry thermograms indicated three thermal events for both PLLA-SCA and PLLA-GA. For PLLA-SCA, the first two events occurred between 65 °C and 90 °C, and the third event occurred at 165 °C. For PLLA-GA all three events occurred between 156 °C and 169 °C. Heating samples to 120 °C and cooling to room temperature prior to differential scanning calorimetry resulted in no thermal events being observed between 65–90 °C with either product, while three events were observed with PLLA-GA and one event with PLLA-SCA between 156 °C and 169 °C. The median volume distribution diameter was 46.4 µm for PLLA-SCA and 31.7 µm for PLLA-GA. Scanning electron microscopy showed PLLA-GA particles were irregular in shape, had no sharp edges and had a wrinkled and crimped surface, while PLLA-SCA particles displayed plate-like shapes and had smoother surfaces. In vivo inflammatory reactivity scores indicated a slight reaction for PLLA-SCA at all time points (3.7 ± 1.1, 6.1 ± 1.6, 5.7 ± 1.2 and 6.2 ± 1.2 at 2, 12, 26 and 52 weeks, respectively), while for PLLA-GA, a moderate reaction was observed at 12 and 26 weeks (2.9 ± 1.5, 10.1 ± 1.0, 9.4 ± 0.7 and 7.1 ± 1.3 at 2, 12, 26 and 52 weeks, respectively). PLLA-SCA and PLLA-GA had similar persistence scores at 2, 12 and 26 weeks, while at 52 weeks the score was markedly higher for PLLA-SCA versus PLLA-GA (1.9 ± 0.2 versus 0.7 ± 0.2). In conclusion, PLLA-SCA is more amorphous than PLLA-GA. The single melting point of PLLA-SCA contrasts with the broader spectrum of melting points for PLLA-GA suggests a more homogenous formulation of PLLA-SCA. This, and its less crystalline structure, result in the slower degradation rate and more sustained biological response of PLLA-SCA compared with PLLA-GA. The physiochemical properties of PLLAs affect the biological response in clinical practice and should be taken into consideration when selecting a PLLA treatment for aesthetic use.

The objective of this study was to evaluate thermal properties and crystallinity of two poly-L-lactic acid (PLLA) injectable implants, Sculptra® (PLLA-SCA) and GANA V® (PLLA-GA), and the extent to which these properties might impact their biological response. PLLA-SCA and PLLA-GA (800mg/sample) underwent differential scanning calorimetry and X-ray powder diffraction to evaluate their thermal properties and degree of crystallinity. X-ray powder diffraction spectra displayed a sharper, more intense peak for PLLA-GA than PLLA-SCA, with smaller peaks on either side of the main peak of PLLA-GA but not PLLA-SCA. Differential scanning calorimetry thermograms indicated three thermal events for both PLLA-SCA and PLLA-GA. For PLLA-SCA, the first two events occurred between 65°C and 90°C and the third event occurred at 165°C. For PLLA-GA all three events occurred between 156°C and 169°C. Heating samples to 120°C and cooling to room temperature prior to differential scanning calorimetry resulted in no thermal events being observed between 65–90°C with either product, while three events were observed with PLLA-GA and one event with PLLA-SCA between 156°C and 169°C. In conclusion, PLLA-SCA is more amorphous than PLLA-GA. The single melting point of PLLA-SCA contrasts with the broader spectrum of melting points for PLLA-GA suggests a more homogenous formulation of PLLA-SCA. This, and its less crystalline structure, result in the slower degradation rate and more sustained biological response of PLLA-SCA compared with PLLA-GA. The physiochemical properties of PLLAs affect the biological response in clinical practice and should be taken into consideration when selecting a PLLA treatment for aesthetic use.

Regenerative medicine aims to restore the structure and function for improved tissue health; reduced tissue health can arise from causes such as aging, which results in the ongoing degradation of the extracellular matrix (ECM) of the skin. Replacement of a single biological component is not sufficient for an esthetic treatment to be described as regenerative; it is the relative amounts, ratios, types and organization of stimulated components that are important in a treatment’s regenerative potential. Regenerative aesthetics aims to recapture the youthful structure and function of tissue by exploiting the body’s own systems. Poly-L-lactic acid (PLLA-SCA; Sculptra^®), an injectable, biodegradable, non-permanent biostimulator, induces a combination of mechanotransductional/mechanical stimulation and foreign body reaction response and promotes ECM remodeling via the production of collagen through the upregulation of cytokines interleukin-1b and CXCL6, elastin, proteoglycans and multiadhesive glycoproteins. In addition, PLLA-SCA stimulates adipocyte rejuvenation/adipogenesis and increases the thickness of the dermis and adipose layers. Hence, PLLA-SCA stimulates endogenous pathways, and the array of biostimulatory effects should not be considered individually but as interlinked with the overall goal of improvement in skin health. These effects manifest clinically as long-term improvements in the mechanical properties of the skin, the restoration of volume and elasticity, improvements in skin quality and thickness, and dermal remodeling.