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

Abstract

BACKGROUNDCorrection of cheek wrinkles using poly-l-lactic acid (PLLA-SCA) was demonstrated in a 12-month study.OBJECTIVEThis analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data.METHODSSubjects 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.RESULTSThe 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