Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Itraconazole 100mg capsules; Itraconazole 200mg tablets; Placebo tablets
Intervention description: 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.
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1381.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Nail fungus; Onychomycosis; Itraconazole; Toenail

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of onychomycosis of at least one great toenail

          -  Percent Nail Involvement Score of the more severely affected great toenail (the Target
             Toenail) must be between 2 and 3 (25-75% of the nail unit).

          -  Length of Unaffected Part of the Target Toenail ≥2mm

          -  Direct microscopic examination with KOH that is positive for the hyphae associated
             with dermatophytes on the target toenail

          -  Subjects must have signed informed consent

          -  If the subject is woman of childbearing potential, she must have a negative urine
             pregnancy test and agree to use an effective form of birth control until the first
             menses after 60 days following the last dose of study medication.

        Exclusion Criteria:

          -  Onychomycosis caused by Candida spp. without the presence of a dermatophyte

          -  Participation in a clinical trial for the systemic treatment of onychomycosis of the
             toenail within 24 weeks prior to Visit 1

          -  Use of systemic antifungals within 12 weeks prior to Visit 1

          -  Use of topical antifungal nail lacquer within 30 days prior to Visit 1

          -  Use of any other topical onychomycosis treatment on any toenail within 7 days prior to
             Visit 1

          -  Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a
             history of CHF

          -  Known liver disease or a history of liver toxicity with other drugs

          -  Use of systemic immunosuppressants