ABSTRACT Background Periorbital aging, a sign of facial aging, is characterized by infraorbital hollowing, volume loss, wrinkles, and reduced skin elasticity. Poly‐L‐lactic acid (PLLA), a biocompatible and biodegradable filler, provides long‐term rejuvenation by stimulating collagen regeneration. Aims To evaluate the efficacy and safety of poly‐L‐lactic acid (PLLA) filler for periorbital rejuvenation, with a focus on improving infraorbital hollowing and associated skin quality parameters. Materials and Methods A prospective single‐arm clinical study was conducted in 30 subjects with moderate‐to‐severe infraorbital hollowing. Subjects received three PLLA injections at 4‐week intervals. Assessments were conducted at baseline ( T0 ), prior to the second ( T1 ) and third treatments ( T2 ), and at 4, 12, and 24 weeks after the third treatment ( T3 , T4 , T5 ). The primary efficacy endpoint was defined as the proportion of subjects achieving at least a 1‐grade reduction in the Allergan Infraorbital Hollows Scale ( AIHS ) on both the left and right sides at 24 weeks after the final treatment ( T5 ). Secondary outcomes included objective assessments based on Antera 3D imaging, including the average volume of bilateral infraorbital hollowing, wrinkle score, black area, and hemoglobin area. Clinical evaluation of skin depression was performed using the Allergan Infraorbital Scale ( AIRS ), and patient‐reported outcomes were assessed using the Global Aesthetic Improvement Scale ( GAIS ). Safety was evaluated by recording adverse events throughout the study period. Results At 24 weeks after the final treatment (T5), 26 of 30 subjects (86.7%; 95% CI, 70.3%–94.7%) achieved the primary endpoint of at least a 1‐grade improvement in AIHS on both sides. Separately, 86.7% and 93.3% of subjects showed at least a 1‐grade improvement on the left and right sides, respectively. Wrinkle score and black area decreased significantly, while hemoglobin area score increased significantly at multiple post‐treatment time points. AIRS scores also demonstrated significant improvement across all time points. All subjects reported aesthetic improvement on the GAIS. No severe complications were reported. Conclusion In this small prospective single‐arm study, PLLA filler was associated with improvements in infraorbital hollowing and selected periorbital skin quality parameters and was generally well tolerated, with no severe adverse events observed during follow‐up. However, given the small sample size and lack of a control group, these findings should be interpreted with caution. These preliminary findings warrant confirmation in larger controlled studies.
Zhang et al. (Mon,) studied this question.