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

Abstract

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.

Figure 1.

Treatment and visit schedule. Subjects were randomized 2:1 to receive PLLA-SCA or no treatment (control). A maximum of 9 mL of PLLA-SCA was administered by subdermal injection in each cheek on Day 1. Up to 3 additional treatments were allowed at monthly intervals until Month 3. Follow-up visits were conducted at Months 7, 9, and 12. PLLA-SCA, poly-l-lactic acid-Sculptra.

Figure 2.

Left (A) and right (B) mean midface volume projection at Month 9 in subjects with a baseline at-rest GCWS severe score treated with either PLLA-SCA (n = 46) or control (n = 21). GCWS, Galderma Cheek Wrinkle Scale; PLLA-SCA, poly-l-lactic acid-Sculptra.

Figure 3.

Mean midface volume change and mean maximum projection at Month 9 in subjects with a baseline at-rest GCWS severe score treated with either PLLA-SCA (n = 46) or control (n = 21). GCWS, Galderma Cheek Wrinkle Scale.

Figure 4.

Left (A), right (B), and volume change image analysis (C) at Month 9 of a 63-year-old woman with a baseline at-rest GCWS severe score who received 4 treatments with PLLA-SCA (4.5 mL per cheek/session). GCWS, Galderma Cheek Wrinkle Scale.