• Josefina Royo de la Torre, J Moreno-Moraga, Maria J Isarría, Estefania Muñoz, Irene Cruz, Gema Pérez, and Paloma Cornejo.
• Servicio de Dermatología, Instituto Médico Láser, Madrid, Spain. consulta@iml.es
• J Drugs Dermatol. 2013 Mar 1; 12 (3): e46-52.

BackgroundPain management is an important objective in procedures involving dermal fillers composed of hyaluronic acid (HA).ObjectiveTo compare the 1-year clinical results of filling the nasolabial fold with 2 types of filler: large-gel particle HA and large-gel particle HA plus 0.3% lidocaine (HA+L). We compared the level of pain during treatment and 10 minutes after treatment and assessed the safety and efficacy profile, satisfaction, and histological findings (using reflectance confocal microscopy [RCM]).Materials And MethodsWe performed a comparative, parallel-group, double-blind trial with an external observer (blinded to the type of treatment administered). The filler was applied to the nasolabial fold in 119 patients (HA in 62 patients and HA+L in 57). Patients were followed at months 3, 9, and 12. Pain was evaluated using a visual analog scale. Efficacy and satisfaction were evaluated using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale. RCM images (n=32) were taken at baseline and at months 3 and 12.ResultsPain: The severity of pain was decreased in patients treated with HA+L on application (P <.001) and 10 minutes later ( P=.008). Efficacy and satisfaction: No significant differences existed between the 2 groups at months 3, 9, and 12. RCM: Skin rejuvenation occurred with a 32% increase in the height of the dermoepidermal junction at month 12 (P <.001), which was similar in both groups. Adverse events: At month 3, the most common adverse events (AEs) were erythema (68%) and hematoma (11%). No AEs were recorded at months 9 or 12.ConclusionThe use of HA+L provides pain relief without affecting efficacy, satisfaction, safety, or the duration of results. RCM showed that the changes in the dermoepidermal junction represented a histological improvement in the skin with similar results in both groups.

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