Multicenter, Randomized Split-Face Trial of a Crosslinked Hyaluronic Acid Fillers With Lidocaine for Nasolabial Fold...

Nasolabial folds (NLFs) are common age-related facial lines, often treated with dermal fillers. Princess FILLER Lidocaine (PFL; now saypha filler Lidocaine) and Juvéderm Ultra XC (JUXC) are both hyaluronic acid-based fillers used for this purpose.

The aim of the authors of this study is to evaluate the effectiveness and safety of PFL in reducing NLF severity compared with JUXC using a split-face study design.

In this randomized, subject- and investigator-blinded multicenter study, patients with moderate-to-severe NLFs received PFL on one side of the face and JUXC on the other. Baseline NLF severity was assessed using the 5-point NLF-Severity Rating Scale (NLF-SRS). Follow-up assessments occurred at Weeks 12, 24, 36, and/or 48. The primary endpoint was the proportion of NLF-SRS responders at Week 24. Secondary endpoints included assessments by photographic reviewers and treating investigators, along with Global Aesthetic Improvement Scale (GAIS) ratings. Safety was monitored by adverse event reporting and patient diaries. FACE-Q questionnaires evaluated patient satisfaction. Repeat treatment was permitted at Week 36 or 48 if needed.

At Week 24, PFL demonstrated noninferiority to JUXC (82.2% vs 81.9% responders; difference 0.37%, P < .0001). Secondary assessments confirmed this finding. Adverse events occurred in 24.4% of patients post PFL, with most being mild to moderate. Serious treatment-emergent adverse events were rare (1.1%).

PFL is a noninferior alternative to JUXC for treating moderate-to-severe NLFs, with comparable efficacy, safety, and patient satisfaction.

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