Onychomycosis, Toenail Onychomychosis, Toenail Fungus. Clinical Trial
Official title:
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.
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment