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Clinical Outcomes of an Innovative Poly-L-Lactic Acid (LASYNPRO) in Facial Rejuvenation: Prospective, Multicenter
Fernando Urdiales-Gálvez1, Paula A Benítez2, Iratxe Díaz3
1Instituto Médico Miramar, Málaga, Spain.
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.
