title: A multicenter, placebo-controlled, double-blind study of intermittent therapy with itraconazole for the treatment of onychomycosis of the fingernail.
abstract: BACKGROUND
  Onychomycosis is the most frequent cause of nail disease and represents 30% of all mycotic infections of the skin.
  
  
  OBJECTIVE
  Our purpose was to compare the effectiveness and tolerability of intermittent dosing of itraconazole ("pulse therapy") with placebo in fingernail onychomycosis.
  
  
  METHODS
  Seventy-three patients with clinically and mycologically diagnosed fingernail onychomycosis were randomly selected to receive itraconazole, 200 mg twice daily, or placebo for the first week of each month for 2 consecutive months; patients were observed for 19 weeks. Seventy-one patients received the study medication and were included in the safety analysis. Efficacy of treatment was evaluated in 46 patients.
  
  
  RESULTS
  A significantly greater proportion of itraconazole-treated patients than placebo-treated patients achieved clinical success (77% vs 0%), mycologic success (73% vs 13%), and overall success (68% vs 0%). No itraconazole-treated patient had a clinical or mycologic relapse during the follow-up period. Ten itraconazole-treated patients (28%) and nine placebo-treated patients (26%) had adverse events. Three patients discontinued treatment for safety reasons.
  
  
  CONCLUSIONS
  Pulse therapy with itraconazole for 2 consecutive months produces significantly greater clinical, mycologic, and overall success than placebo. Short-term itraconazole pulse therapy for fingernail onychomycosis is effective and well tolerated.
authors.affiliation: University of California, San Francisco, USA.
authors.forename: R B
authors.initials: RB
authors.lastname: Odom
authors.forename: R
authors.initials: R
authors.lastname: Aly
authors.forename: R K
authors.initials: RK
authors.lastname: Scher
authors.forename: C R
authors.initials: CR
authors.lastname: Daniel
authors.forename: B E
authors.initials: BE
authors.lastname: Elewski
authors.forename: N
authors.initials: N
authors.lastname: Zaias
authors.forename: R
authors.initials: R
authors.lastname: DeVillez
authors.forename: M
authors.initials: M
authors.lastname: Jacko
authors.forename: N
authors.initials: N
authors.lastname: Oleka
authors.forename: B L
authors.initials: BL
authors.lastname: Moskovitz
mesh_terms: D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006229:Hand Dermatoses / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D015228:Hypertriglyceridemia / Q000139:chemically induced; D017964:Itraconazole / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy*; D011537:Pruritus / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole