RESUMEN
Background: Limited long-term safety data are published on HA/CaHA/L, a hybrid dermal filler combining hyaluronic acid (HA), calcium hydroxyapatite (CaHA), and lidocaine (L). Methods: This retrospective multicenter study assessed treatment-emergent adverse events (TEAEs) in adults treated with HA/CaHA/L. The full analysis set (FAS) included eligible consented adults (Nâ =â 403); the long-term safety analysis (LTSA) set included FAS participants with greater than or equal to 12-months HA/CaHA/L exposure (nâ =â 243). Results: Participants were majority female (94.0%), with Fitzpatrick skin phototypes II/III (80.1%) and a mean age of 50.1 years. Most participants (86.4%) received one HA/CaHA/L treatment. The median time between participants' first HA/CaHA/L treatment and chart review was 15.4 months. Participants received a mean of 2.2 mL (0.5-8.9 mL) filler per treatment. Treated areas were predominantly malar (71.2%) and mandible (69.7%) regions. Most participants (95.0%) had one or more aesthetic treatments other than HA/CaHA/L [eg, other dermal fillers (84.1%), botulinum toxin (63.3%)]. Nineteen (4.7%) FAS participants had 20 documented TEAEs; most (3.5%, nâ =â 14 participants) were mild in severity. Twelve TEAEs in 11 participants (2.7%) were related to HA/CaHA/L: induration (three, 0.7%), edema (3, 0.7%), and implant site nodules (five, 1.2%), which were noninflammatory and likely related to product placement. Among the LTSA, 15 (6.2%) participants had 16 documented TEAEs (six edema, five implant site nodules, one inflammation, three skin induration, one hypersensitivity); most were mild in severity. Nine TEAEs in eight participants (3.3%) were HA/CaHA/L-related. No treatment-emergent serious AEs were reported. Conclusion: The data from this noninterventional retrospective study support the favorable longer term (>12 month) safety profile of HA/CaHA/L.
RESUMEN
Introdução: o prognóstico do câncer de pele está diretamente relacionado ao diagnóstico precoce. As campanhas nacionais de prevenção ao câncer de pele (CNPCPs) consistem em um importante veículo de prevenção e detecção das lesões malignas de pele. Objetivos: investigar a incidência do câncer de pele e a acurácia da dermatoscopia em pacientes atendidos na CNPCP. Métodos: um estudo de coorte retrospectiva foi realizado utilizando diretamente os dados coletados da população atendida no dia da CNPCP dos anos de 2016, 2017 e 2018 no Centro Clínico da Universidade de Caxias do Sul (CECLIN-UCS). Resultados: dos 634 pacientes incluídos no estudo, 105 foram encaminhados para realização de biópsia com estudo histopatológico da lesão. A dermatoscopia foi sugestiva de lesão maligna em 55 casos. A biópsia diagnosticou lesões malignas em 43 pacientes e lesões benignas em 32 pacientes. Sendo assim, no estudo, a sensibilidade e a especificidade do exame foram de, respectivamente, 86 e 50%. Pode-se concluir que a acurácia da dermatoscopia na identificação de lesões malignas ao longo dos três anos de campanha foi de cerca de 70%. Conclusões: a dermatoscopia nas CNPCPs apresenta um bom nível de sensibilidade e especificidade quando correlacionada aos resultados finais de exame histopatológico
Introduction: Skin cancer is the most frequent malignant neoplasm in Brazil. Its prognosis is directly related to early diagnosis and institution of adequate treatment. The Skin Cancer National Awareness Campaign (SCNAC) is an essential tool to prevent and detect malignant skin lesions. Objectives: To investigate the incidence of skin cancer and the accuracy of dermoscopy in patients assessed at the SCNAC. Methods: We conducted a retrospective cohort study using directly the data collected from the population assisted at the SCNAC day in 2016, 2017, and 2018 at Clinical Center of the Universidade de Caxias do Sul (CECLIN-UCS). Results: Of the 634 patients included, 105 were referred for biopsy with histopathological study of the lesion. Dermoscopy was suggestive of a malignant lesion in 55 cases. Biopsy diagnosed malignant lesions in 43 patients and benign lesions in 32 patients. Thus, the sensitivity and specificity of the test were 86% and 50%, respectively. The accuracy of dermoscopy in identifying malignant lesions over the three years of the campaign was around 70%. Conclusions: Dermoscopy in SCNAC has a good level of sensitivity and specificity when correlated with final histopathological results
