Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.

This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1&2 and Cohort 3.

Inclusion criteria

• Subjects must meet all of the following criteria to be included in the study:
• Witnessed, signed informed consent approved by Ethics Committee.
• Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening.
• For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.
• Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed.
• The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm.
• Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth.
• Normal or not clinically significant screening safety labs.

Exclusion criteria

• Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study.
• Diabetes mellitus requiring treatment other than diet and exercise.
• Subjects with chronic moccasin type of T. pedis.
• Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
• Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study.
• Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:

• Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
• Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
• Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:

• Corticosteroids (including intramuscular injections): 2 weeks
• Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes: 24 weeks
• Systemic immunomodulators: 4 weeks
• Treatment of any type for cancer within the last 6 months.
• History of any significant internal disease.
• Subjects with a medical history of current or past psoriasis of the skin and/or nails.
• Concurrent lichen planus.
• Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
• Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated.
• AIDS or AIDS related complex.
• History of street drug or alcohol abuse.
• Any subject not able to meet the study attendance requirements.
• Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study.