Phase 3
Completed N=1,381
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Onychomycosis
Source: ClinicalTrials.gov NCT00356915 ↗
Enrolled (actual)
1,381
Serious AEs
1.0%
Results posted
Jan 2012
Primary outcomePrimary: Clinical and Mycological Cure of Target Toenail — 22.3; 1 Percentage of participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical and Mycological Cure of Target Toenail |
22.3; 1 | <0.001 sig |
| PRIMARY Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules |
22.3; 21.7; 1.0 | — |
| SECONDARY Clinical Improvement of the Target Toenail |
33.7; 29.3 | < 0.001 sig |
| SECONDARY Clinical Improvement Compared to Placebo |
33.7; 2 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT00356915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.