Midface Projection Using Biostimulatory Poly- l -Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial.

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.