title: Use of itraconazole in the treatment of mucocutaneous leishmaniasis: a pilot study.
abstract: OBJECTIVE
  Mucocutaneous leishmaniasis is widely distributed in Brazil, with Leishmania (Viannia) braziliensis being the major etiologic agent. The currently recommended therapy is limited by its parenteral use, high toxicity, and variable efficacy. A clinical pilot study was conducted to analyze itraconazole as an oral alternative for the treatment of mucocutaneous leishmaniasis.
  
  
  METHODS
  Ten patients were enrolled to receive 4 mg/kg per day (up to 400 mg/d) itraconazole for 6 weeks on an outpatient regimen. Diagnosis was based on clinical otorhinolaryngologic examination, followed by a specific serologic reaction, the Montenegro test and pathologic analysis with immunohistochemical reaction. Healing of the lesions was confirmed by clinical otorhinolaryngologic examination. Side effects were monitored by general clinical assessment, hemoglobin determination, leukocyte counts, and liver function tests, all performed before, during, and 1 month after the end of treatment.
  
  
  RESULTS
  Six of 10 patients presented healed lesions 3 months after treatment, with a sustained therapeutic response for at least a median period of 14.5 months (range, 12-18 mo). Side effects were not observed.
  
  
  CONCLUSIONS
  This pilot study demonstrated that itraconazole can be an effective and well-tolerated alternative for the treatment of mucocutaneous leishmaniasis. Further randomized studies and double blind controlled trials are needed to assess the benefits of this drug in the treatment of mucocutaneous leishmaniasis.
authors.affiliation: Department of Infectious and Parasitic Diseases, Clinics Hospital of University of São Paulo, School of Medicine, São Paulo, Brazil. valdirsa@netpoint.com.br
authors.forename: V S
authors.initials: VS
authors.lastname: Amato
authors.forename: A R
authors.initials: AR
authors.lastname: Padilha
authors.forename: A C
authors.initials: AC
authors.lastname: Nicodemo
authors.forename: M I
authors.initials: MI
authors.lastname: Duarte
authors.forename: M
authors.initials: M
authors.lastname: Valentini
authors.forename: D E
authors.initials: DE
authors.lastname: Uip
authors.forename: M
authors.initials: M
authors.lastname: Boulos
authors.forename: V A
authors.initials: VA
authors.lastname: Neto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D007897:Leishmaniasis, Mucocutaneous / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D017964:Itraconazole