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Itraconazole Tablets vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail

This page will post information on clinical trials in dermatology. If you are interested in participating contact one of the sites near you or the study sponsor.

Condition:

Onychomycosis (nail fungus) of the toenail

Name of study:

Itraconazole Tablets vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail

Sponsor:

Barrier Therapeutics Inc.

Status:

Recruiting

Purpose and Description of Study:

Onychomycosis (nail fungus) is a common condition accounting for about half of all nail disorders. Itraconazole (Sporanox®) is an oral drug in capsule form approved by government health authorities for the treatment of onychomycosis of the toenail. This clinical trial will compare the efficacy and safety of a new once-a-day tablet formulation of itraconazole with two itraconazole capsules a day or placebo, taken for 12 weeks. After completing the12 week course of therapy, toenails will be assessed for signs of fungal infection at weeks 26, 39 and 52.

Treatment:

Itraconazole capsules (Sporanox®)
Itraconazole tablets (investigational medication)

Phase:

3

Study Design:

Randomized, Single Blind, Placebo Control, Safety and Efficacy Study

Expected Total Enrollment:

1268

Eligibility:

age 16-75 years

Inclusion/Exclusion Criteria:

Main Inclusion Criteria:

  • Clinical diagnosis of onychomycosis of at least one great toenail
  • Fungal infection must cover between 25-75% of the target toenail
  • Fungal infection must be confirmed by both microscope and mycology sample testing
  • Women of childbearing potential must not be pregnant and agree to use an effective form of birth control during treatment and for 60 days after the last dose of study medication.

Main Exclusion Criteria:

  • Use of oral antifungals within 12 weeks prior to visit one.
  • Use of topical antifungal nail liqueur within 30 days prior to visit one.
  • History of congestive heart failure.
  • Liver disease
  • Use of medications that are prohibited with Sporanox® treatment

Location of Clinical Trial Sites and Contact Information

Study Director:   Lynne Bulger (lbulger@barriertherapeutics.com)

Choose your location:

Canada    |     United States

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