Study of Different Doses of a Novel Treatment for Onychomycosis

Exclusion Criteria

• •1. 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.
• •2. Diabetes mellitus requiring treatment other than diet and exercise.
• •3. Subjects with chronic moccasin type of T. pedis.
• •4. Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
• •5. 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.
• •6. 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:
• •1. Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
• •2. Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
• •7. 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:
• •1. Corticosteroids (including intramuscular injections): 2 weeks
• •2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
• •3. Systemic immunomodulators: 4 weeks
• •8. Treatment of any type for cancer within the last 6 months.
• •9. History of any significant internal disease.
• •10. Subjects with a medical history of current or past psoriasis of the skin and/or nails.
• •11. Concurrent lichen planus.
• •12. 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.
• •13. Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated.
• •14. AIDS or AIDS related complex.
• •15. History of street drug or alcohol abuse.
• •16. Any subject not able to meet the study attendance requirements.
• •17. 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