ABOUT THIS STUDY
1. Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee.
2. Male or female subjects of any race at least 18 years of age but not older than 65 years of age.
3. Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for a dermatophyte.
4. Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) by visual inspection after the nail has been trimmed.
5. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed < 3 mm.
6. 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.
7. Normal or not clinically significant screening safety labs.
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
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
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