Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: SUBA-itraconazole; Itraconazole; Placebo
Intervention description: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd); 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).; Two placebo capsules taken approximately 30 minutes prior to breakfast
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis

Summary:

      The objective of this study is to compare the relative efficacy and safety of
      SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of
      itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of
      onychomycosis of the toenail. Both the test and the reference formulations will also be
      compared to a placebo formulation to test for superiority.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant, non lactating females 18 years of age or older.

          2. Signed informed consent form, which meets all criteria of current FDA regulations.

          3. If female and of child bearing potential, have a negative urine pregnancy test at the
             baseline and randomization visits and prepared to abstain from sexual intercourse or
             use a reliable method of contraception during the study (e.g., condom with spermicide,
             inter-uterine device, oral, injected, transdermal or implanted hormonal
             contraceptives).

          4. Clinical diagnosis of onychomycosis of at least one great toenail

          5. Clinical signs and symptoms of onychomycosis of the most severely affected great
             toenail of at least moderate severity as defined by at least 25% but no more than 75%
             of the most infected toenail and a combined severity score of at least 4 using the
             Nail Infection Rating Scale (see Appendix A).

          6. At least 2mm of clear nail on the most affected toe between the proximal nail fold and
             the deepest extend of the onychomycosis.

          7. Positive potassium hydroxide (KOH) stain for confirmation of fungal nail infection

          8. Positive mycological culture for known fungal dermatophyte consistent with
             onychomycosis infection of at least one of the great toenails.

        Exclusion Criteria:

          1. Females who are pregnant, lactating or likely to become pregnant during the study.

          2. Negative KOH stain

          3. Negative mycological culture for fungal dermatophytes consistent with onychomycosis
             infection.

          4. Combined score of less than 4 on the Nail Infection Rating Scale for the most severely
             affected great toenail.

          5. Patient has superficial onychomycosis or significant dystrophy of the target toenail
             that in the Investigators opinion would impair the evaluation of onychomycosis.

          6. Patient has total dystrophic or proximal subungual onychomycosis of the target
             toenail.

          7. Presence of mycotic spikes or patient has exclusively lateral groove involvement of
             the target toenail.

          8. Less than 25% or more than 75% of the most severely infected great toenail affected.

          9. Target toenail thickness is greater than 3mm.

         10. No new nail growth in the target nail over the previous 6 months.

         11. Onychomycosis not caused by a dermatophyte (e.g. mold infection, Candida spp or
             bacterial infection).

         12. Previous treatment for onychomycosis of the toenail within the last 12 months that was
             unresponsive to treatment.

         13. Previous treatment within the previous 2 months with any systemic antifungal therapy
             or within the previous 2 weeks with any topical antifungal therapy.

         14. Significant history or current evidence of chronic infectious disease, system
             disorder, organ disorder or other medical condition that in the Investigator's opinion
             would place the study patient at undue risk by participation or could jeopardize the
             integrity of the study evaluations.

         15. Immunocompromised either because of concomitant disease (e.g. HIV), or ongoing
             treatment (e.g. chemotherapy).

         16. Current or history of psoriasis within the previous 12 months.

         17. Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a
             history of CHF.

         18. History of diabetes.

         19. Previous hypersensitivity to imidazole or azole compounds.

         20. Liver Function Test results at screening more than twice the upper limit of normal
             range or other hematology or clinical chemistry test results that would contraindicate
             dosing with itraconazole.

         21. Use within the previous 3 months or anticipated use during the study of any drugs that
             are known to affect the bioavailability of oral itraconazole or are otherwise
             contraindicated to be taken with itraconazole as detailed in the product labeling for
             SPORANOX® (Appendix B).

         22. Receipt of any drug as part of a research study within 30 days prior to dosing.

         23. Previous dosing in this study.