RESUMO
INTRODUCTION: The emergence of hyaluronic acid dermal fillers with lidocaine has transformed the minimally invasive treatment of wrinkles, lines and folds of the face. Patients can be treated quickly, painlessly and without the need for large doses of lidocaine. Therefore, it is important to scientifically evaluate the merits of lidocaine-containing products over those without. METHODS: The two products, with (UJU) and without lidocaine (UJ), were randomly injected into nasolabial folds of 75 healthy volunteers with varying skin types in a split face study, age ranging 26-60 years. Only 73 subjects completed the follow-up. There were 68 females and 5 males with medium-to-deep nasolabial folds. All subjects were randomly injected with the two products on one or the other side of the face. Patients were followed up for 9 months. RESULTS: Both products achieved significant improvement in the wrinkle severity score. Overall results were slightly better with UJU due to ease of injection, lack of pain and avoidance of topical or parenteral anaesthetic. In all other respects, differences in clinical data were not statistically significant. UJU® was preferred by patients and injectors due to less pain during and after injection as compared to UJ® (P < 0.0001). The overall rate of early and late complications with the two products was similar. Duration of maintenance of aesthetic effect between products also showed similarity. Optimum aesthetic effect was maintained in most cases for over 9 months with both products but patients in the 30-50-year age group did better. The patient acceptability rate was much higher with UJU. CONCLUSION: Clinical data from this study suggest that performance and outcomes of treatment of medium-to-deep nasolabial folds with UJ and UJU are quite similar. However, treatment with UJU offers enhanced patient comfort and is preferred by patients and injectors. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
