Abstract
INTRODUCTION: Fractional microneedle radiofrequency (FMRF) and poly-L-lactic acid (PLLA) each promote dermal remodeling through distinct mechanisms and have demonstrated efficacy as monotherapies for atrophic acne scars (AAS). The objective of this study is to evaluate the efficacy and safety of combining FMRF with transdermal PLLA delivery compared with sterile water in Asian patients with moderate-to-severe AAS. METHODS: In this randomized, split-face, evaluator-blinded clinical trial, 24 participants underwent two monthly FMRF sessions. Immediately after each session, a reconstituted PLLA suspension was applied to one facial half for transdermal delivery through the FMRF-created microchannels, while sterile water was applied to the contralateral side. Outcomes were assessed using three-dimensional imaging (Antera® 3D), standardized photography, and patient self-assessments over a 6-month follow-up. Safety was monitored throughout the study. RESULTS: PLLA-treated sides demonstrated statistically significant improvements in skin texture and scar volume at 6 months compared with baseline and with control sides (p < 0.05). Patient-reported outcomes paralleled objective findings, with a higher proportion of participants reporting > 75% improvement on the PLLA-treated side. Adverse events were of low incidence, transient, self-limited, and no serious complications occurred. CONCLUSIONS: Combining FMRF with transdermal PLLA delivery is a safe and effective approach for moderate-to-severe AAS in Asian patients. The combination produced progressive, sustained, and clinically meaningful improvements compared with FMRF alone. TRIAL REGISTRATION: Thai Clinical Trials Registry: TCTR20250803007.