At a glance
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A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.
In Brief
A Phase 3 clinical trial evaluating Itraconazole 100mg capsules, Itraconazole 200mg tablets, and 1 other intervention for Onychomycosis. Completed, enrolled 1,381 participants across 68 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.