Efficacy and Safety of a Poly-L-Lactic Acid Filler for Temporal Augmentation: A Randomized, No-treatment Control, Evaluator-blinded, Multicenter Study.

Summary

In a multicenter randomized, evaluator-blinded trial (n=174), PLLA injections produced robust improvement in temple hollowing, with 96.5% achieving ≥1-grade ATHS improvement at 6 months versus 0% in controls. Gains across GAIS, 3D volumetry, and satisfaction persisted to 12 months, with no therapy-related adverse events observed.

Key Findings

• At month 6, 96.5% of treated participants achieved ≥1-grade ATHS improvement vs 0% in controls (P < 0.0001).
• Consistent improvements across GAIS and 3D-measured temporal volume persisted through 12 months.
• No therapy-related adverse events were reported; PLLA was well tolerated.

Clinical Implications

PLLA offers a minimally invasive, durable option for temple hollowing with high patient satisfaction. It can be considered as an alternative to hyaluronic acid or fat grafting, while head-to-head comparative and longer-term (>12 months) data are still needed.

Limitations

• No active comparator (e.g., hyaluronic acid or fat grafting); control was no-treatment
• Follow-up limited to 12 months; long-term durability beyond one year is unknown

Future Directions

Head-to-head trials versus hyaluronic acid and fat grafting, optimization of injection protocols, and longer-term (>24 months) outcomes including late adverse events.