ABSTRACT Objective To evaluate the clinical efficacy, patient satisfaction, safety profile, and biological impact of Poly‐L‐lactic acid (PLLA LASYNPRO) over 6 months. Methods This prospective, multicenter study included patients treated with PLLA‐LASYNPRO. The primary end‐point was the proportion of participants who achieved a reduction of at least 1 point in the Wrinkle‐Severity‐Rating‐Scale (WSRS). Secondary end‐points included the proportion of participants achieving at least a 1‐point reduction in the Midface‐Volume‐Deficit‐Scale (MFVDS), the degree of patient satisfaction assessed by the Global‐Aesthetic‐Improvement‐Scale (GAIS), treatment‐related biological and structural changes, and the incidence of adverse events (AEs). Results Thirty‐six female subjects were enrolled. Right‐side treatment success rates increased from 44.4% at month‐1 to 71.9% at month‐6 (Cochran's Q , p = 0.005); left‐side rates increased from 44.4% to 68.8% ( p = 0.006). MFVDS‐treated‐side success increased significantly (44.4% to 65.6%; p = 0.004). GAIS ratings of “Much Better” or “Better” were reported by 66.7% at month 1 and remained high (65.6% at month‐6). Ultrasound and elastography imaging confirmed increased tissue density, reduction of the Sub‐Epidermal‐Low‐Echogenic‐Band (SLEB), signs of neocollagenesis, and improved viscoelasticity. Serum P1CP levels rose significantly from 134.6 ± 98.9 ng/mL to a peak of 233.2 ± 163.1 ng/mL at month 2 ( p < 0.001 vs. baseline), remaining elevated through month 6 ( p = 0.012). AEs were limited to mild–moderate, self‐resolving inflammation, erythema, edema, and injection‐site discomfort; no serious AEs occurred. Conclusion PLLA‐LASYNPRO achieved significant, sustained improvements in facial wrinkles and volume with high patient satisfaction and biological evidence of collagen stimulation. The treatment demonstrates an excellent safety profile. Further large‐scale, randomized trials are recommended to confirm long‐term efficacy and define its role in aesthetic practice.
Urdiales‐Gálvez et al. (Sun,) studied this question.