Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Onychomycosis is a common condition accounting for approximately half of all nail disorders.
      It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment
      of onychomycosis in the United States with an approved dosage regimen for the treatment of
      onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100
      mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be
      used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare
      the efficacy and safety of this new tablet formulation with itraconazole capsules and
      placebo.
    

Detailed description: 
      Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause
      is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes
      (20%) but may also be due to yeast infection, usually Candida albicans.

      The prevalence of onychomycosis in the United States population as a whole is 13% and is more
      prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a
      genetic component.

      Onychomycosis can result in permanent nail deformity. This disease has a significant impact
      on the patient's quality of life (e.g., concern with the appearance of the toenails and
      fingernails, interference with wearing shoes, walking and sports activities).

      Itraconazole has been approved for the treatment of onychomycosis in the United States since
      the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the
      toenail is once daily (QD) treatment with 200 mg of itraconazole (Sporanox®, Janssen
      Pharmaceutical Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is
      a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a
      more convenient one-tablet-per-day dosing regimen.

      This clinical trial will compare the efficacy and safety of this new tablet formulation with
      itraconazole capsules and placebo.
    

Intervention name(s): Itraconazole 100mg capsules; Itraconazole 200mg tablets; Placebo tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.; Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.; Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.
Other intervention name(s): Sporanox®; Onmel; placebo
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Nail fungus; Onychomycosis; Itraconazole; Toenail