title: Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of onychomycosis.
abstract: BACKGROUND
  Itraconazole, approved for treatment of toenail fungal infection onychomycosis, provides antifungal activity at a dosage requiring once-daily (QD) administration of 2 100-mg capsules for 12 weeks. Utilizing the Meltrex® technology delivery system, a novel 200-mg formulation of itraconazole was developed delivering the same dosage as 2 capsules in a single tablet.
  
  
  METHODS
  This phase 3, randomized, placebo-controlled trial investigated the noninferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsules dosed QD for 12 weeks, with a 40-week follow-up period. Clinical Cure (Investigator's Global Assessment plus mycological examination) was the primary outcome measure and Clinical Improvement was a secondary endpoint. Safety and efficacy of itraconazole 200-mg tablets were also compared with placebo.
  
  
  RESULTS
  Significantly more patients in the intent-to-treat per-protocol populations on itraconazole (200-mg tablet or 2 100-mg capsules) achieved Complete Cure and Clinical Improvement compared with placebo. For both endpoints, itraconazole 200-mg tablet QD was noninferior to itraconazole 100-mg capsules and superior to placebo. All treatment groups demonstrated a similar safety profile with no new safety signals identified.
  
  
  CONCLUSIONS
  Absolute patient blinding was not possible; the number of tablets versus capsules differed, and the appearance of the active drugs could not be masked. However, efficacy was based on objective assessments from blinded investigators.
  
  
  CONCLUSIONS
  Once-daily itraconazole 200-mg was well-tolerated, and may be an effective alternative to 2 itraconazole 100-mg capsules for the treatment of toenail onychomycosis. The convenience of a simpler dosing regimen may improve patient compliance
authors.affiliation: Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Stuart
authors.initials: S
authors.lastname: Maddin
authors.forename: John
authors.initials: J
authors.lastname: Quiring
authors.forename: Lynne
authors.initials: L
authors.lastname: Bulger
mesh_terms: D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002214:Capsules; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy* / Q000473:pathology; D016037:Single-Blind Method; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D002214:Capsules; D013607:Tablets; D017964:Itraconazole