Made available in DSpace on 2014-12-17T14:13:58Z (GMT). No. of bitstreams: 1 ElaineLMB.pdf: 288894 bytes, checksum: f70a81fe61f9c843b53868be13773200 (MD5) Previous issue date: 2007-06-22 / PURPOSE: To evaluate the capacity of clofazimine (CFZ) to control cutaneous activity of systemic lupus erythematosus (SLE), compared with chloroquine diphosphate (CDP). METHODS: A prospective, randomized, controlled, double blind clinical trial was carried out in thirty-three patients with SLE and cutaneous lesions (malar rash and/or discoid lupus and/or subacute cutaneous lupus), after approval by the respective Ethics Committee. Sixteen patients received clofazimine - 100mg/day (CFZ group) and 17 received chloroquine diphosphate - 250mg/day (CDP group), during six months. Both groups applied broad-spectrum sunscreens twice a day. The dose of prednisone was kept stable during the study. Cutaneous lesions were evaluated by 2 blinded observers and photographed at baseline and at months 1, 2, 4 and 6. RESULTS: Thirty-three patients began and 27 completed the 6 months of treatment. The groups were homogeneous and comparable in terms of demographic and clinical characteristics. Five CFZ-patients and one CDP-patients dropped out due to severe flare of disease requiring other treatment. At the end of the study, 12 CFZ-patients (75%) and 14 CDP-patients (82,4%) presented complete or near-complete remission of skin lesions; intention-to-treat analysis showed no significant difference in the response rates between groups. Side effects in both groups were frequent, but patients didn t have to discontinue the drugs. CONCLUSIONS: Clofazimine and chloroquine were effective in controlling cutaneous lesions in SLE patients / Objetivo: Avaliar a efic?cia da clofazimina (CFZ) no tratamento das les?es cut?neas do l?pus eritematoso sist?mico (LES), comparando-a com o difosfato de cloroquina (DFC). M?todos: Ap?s aprova??o pelo Comit? de ?tica em Pesquisa da Universidade Federal do Rio Grande do Norte (UFRN), foi realizado um estudo intervencional duplo-cego, controlado e rand?mico, com 33 pacientes portadores de LES e les?es cut?neas em atividade (eritema malar t?pico e/ou les?o disc?ide e/ou l?pus cut?neo subagudo). Um grupo recebeu 100 mg de CFZ (n=16 pacientes) e o outro grupo recebeu 250 mg de DFC (n=17 pacientes), durante seis meses. Ambos os grupos usaram protetor solar, duas vezes ao dia. Durante o per?odo de observa??o, a dose do corticoster?ide dos pacientes foi mantida est?vel. Resultados: Trinta e tr?s pacientes iniciaram e 27 completaram os 06 meses do estudo. Cinco pacientes do grupo CFZ e um do grupo DFC foram retirados, devido a manifesta??es sist?micas graves do LES, para o tratamento adequado a cada caso. Ao final do estudo, utilizando a an?lise inten??o de tratar , 12 pacientes do grupo CFZ (75%) e 14 do grupo DFC (82,4%) obtiveram melhora completa ou quase completa das les?es cut?neas. Os efeitos colaterais foram freq?entes em ambos os grupos, mas nenhum paciente necessitou interromper o tratamento. Conclus?es: A clofazimina mostrou-se eficaz, semelhante ao difosfato de cloroquina, no controle das les?es cut?neas do LES