Abstract
BACKGROUND: Interventions to enhance lip volume and shape are common aesthetic procedures to counter signs of aging. OBJECTIVES: This study aimed to assess the efficacy of Art Filler Lips (AFL), with or without retouching, at restoring lip shape and volume, tolerability, and persistence over 18 months. METHODS: During this open-label study, AFL (≤2.0 mL) was injected into the upper, lower, and/or both red lips and borders at baseline (D0). Patients were evaluated at D21, when, if necessary, retouching was performed. Patients were evaluated at D42, D90, D180, D270, D360, D450, and D540. The primary assessment was based on evaluation at D21 using the Medicis Lip Fullness Scale (MLFS). Satisfactory volume restoration was defined as an improvement of ≥1 point vs D0. Secondary outcomes were adverse events (AEs), and investigator and patient satisfaction rates based on Global Aesthetic Improvement Scores. RESULTS: Among 73 patients (97% females; 54.4 ± 10.5 years), 56% of lips were injected without any retouch. Mean MLFS scores either for upper and lower lips separately or together, significantly improved by D21 for the patients without retouching or D42 for those with (all P < .0001). At D21/42, 99% of upper lips, 94% of lower lips, and 96% of both lips showed satisfactory volume restoration. This proportion declined between D21/42 and D540. The most reported immediate AEs were swelling, sensitivity, and pain and were mild to moderate, lasting for <2 weeks. CONCLUSIONS: AFL is well tolerated and produces a sustained objective and subjective lip volume restoration and shape.