Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.