What it means for a patient
- PLLA prompts the body to make new collagen. Patients in this study had three sessions.
- At 12 months, the treated side had lower wrinkle scores and more volume than the saline side.
- No lumps (nodules or granulomas) were seen during 12 months. The authors limit this safety finding to this formulation under these study conditions.
- The abstract does not give the volume change in milliliters.
- The saline-treated side of each patient's face served as the comparison.
Why this paper matters
It measured PLLA volume effects with 3D imaging against a saline-treated side of the same face over 12 months. It reported no granulomas or delayed nodules in this group.
Overview
Poly-L-lactic acid (PLLA) is an injectable that restores midface volume by prompting new collagen, in place of filling with a gel. Controlled evidence measuring its volume effect is limited. The authors ran a prospective, evaluator-blinded, split-face controlled study of a Norberg Medical PLLA formulation. Patients were enrolled from July to September 2024, and follow-up was completed in September 2025.
Findings
- 95 patients had three standardized PLLA sessions on one side of the face and saline placebo on the other.
- Each vial held 150 mg of PLLA in spherical microparticles, mixed with 5 mL of sterile water without lidocaine.
- Measures: Wrinkle Severity Rating Scale (WSRS), Vectra H1 3D volume (malar, zygomatic, mandibular), FACE-Q and GAIS.
- Two blinded evaluators rated the WSRS.
- At 12 months, WSRS fell on the PLLA side compared with baseline and with the saline side (Δ = -0.68, P < .001).
- 3D analysis showed sustained volume gain in all midface subunits.
- Agreement between the two evaluators: ICC = 0.91.
- Patients with at least a 1-grade WSRS improvement: 82.1%.
- Patient satisfaction remained high and matched the objective findings.
- Adverse events were mild and transient. No granulomas, nodules or vascular events were recorded.
Terms
- Poly-L-lactic acid (PLLA): a biodegradable injectable that stimulates collagen production.
- Biostimulatory: prompting the body to build its own tissue.
- Collagen neogenesis: formation of new collagen.
- Split-face study: a study in which each side of the face gets a different treatment.
- Saline placebo: salt water injected for comparison.
- WSRS: the Wrinkle Severity Rating Scale.
- Vectra H1: a handheld 3D camera that measures facial volume.
- FACE-Q: a questionnaire of patient-reported outcomes for facial treatments.
- Granuloma: a firm lump formed by the body's reaction to foreign material.
- Intraclass correlation coefficient (ICC): a measure of agreement between raters, from 0 to 1.