title: The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management.
abstract: BACKGROUND
  Pain management is an important objective in procedures involving dermal fillers composed of hyaluronic acid (HA).
  
  
  OBJECTIVE
  To 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]).
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Pain: 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Servicio de Dermatología, Instituto Médico Láser, Madrid, Spain. consulta@iml.es
authors.forename: Josefina
authors.initials: J
authors.lastname: Royo de la Torre
authors.forename: J
authors.initials: J
authors.lastname: Moreno-Moraga
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Isarría
authors.forename: Estefania
authors.initials: E
authors.lastname: Muñoz
authors.forename: Irene
authors.initials: I
authors.lastname: Cruz
authors.forename: Gema
authors.initials: G
authors.lastname: Pérez
authors.forename: Paloma
authors.initials: P
authors.lastname: Cornejo
mesh_terms: D000328:Adult; D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects; D003357:Cosmetic Techniques / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D060052:Nasolabial Fold; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D012060:Rejuvenation; D012720:Severity of Illness Index; D015595:Skin Aging; D013997:Time Factors
chemical_list: D000779:Anesthetics, Local; D005782:Gels; D006820:Hyaluronic Acid; D008012:Lidocaine