title: Treatment of cutaneous leishmaniasis with itraconazole. Randomized double-blind study.
abstract: OBJECTIVE
  To compare the efficacy of itraconazole with placebo in the treatment of cutaneous leishmaniasis caused by Leishmania major.
  
  
  METHODS
  Double-blind placebo-controlled study.
  
  
  METHODS
  Patients were selected from volunteers wit cutaneous leishmaniasis who lived in a hyperendemic area.
  
  
  METHODS
  One hundred forty patients were randomly selected for this double-blind study. Exclusion criteria were pregnancy, gestation, age younger than 12 years, and duration of disease of more than 4 months.
  
  
  METHODS
  Each patient received itraconazole (7 mg/kg per day) or placebo for a 3-week period. The patients were kept under observation for an additional 30-day period. OUTCOME. The study was completed as planned in 131 patients.
  
  
  RESULTS
  Complete healing occurred in 59% of the itraconazole group in comparison with 44.3% of the patients who were treated with placebo capsules. No difference was found between the 2 groups with respect to adverse effects.
  
  
  CONCLUSIONS
  Although itraconazole has the advantage of being an oral agent that is used in the treatment of cutaneous leishmaniasis, the low response rate in patients receiving itraconazole indicates that itraconazole cannot be used as the single agent in the treatment of patients with cutaneous leishmaniasis caused by L. major.
authors.affiliation: Isfahan University of the Medical Sciences, Iran.
authors.forename: A Z
authors.initials: AZ
authors.lastname: Momeni
authors.forename: T
authors.initials: T
authors.lastname: Jalayer
authors.forename: M
authors.initials: M
authors.lastname: Emamjomeh
authors.forename: N
authors.initials: N
authors.lastname: Bashardost
authors.forename: R L
authors.initials: RL
authors.lastname: Ghassemi
authors.forename: M
authors.initials: M
authors.lastname: Meghdadi
authors.forename: A
authors.initials: A
authors.lastname: Javadi
authors.forename: M
authors.initials: M
authors.lastname: Aminjavaheri
mesh_terms: D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole