Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)
Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)
The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's
 effect on the clinical signs and symptoms associated with Tinea Pedis
Inclusion Criteria:

 -  Positive clinical findings for moccasin, interdigital or bullous tinea pedis as
 determined by direct clinical examination

 -  Must have a clinical symptom severity score of at least 20 on a possible 64 point
 scale

 -  Written informed consent must be obtained from the subject.

 -  Must ≥ 19 years of age

 -  Must agree to avoid professional pedicures or application of any nail polish product
 or nail cosmetic to the toenails after the screening visit until the conclusion of the
 trial.

 -  Must agree to take measures to avoid pregnancy during the 12 day (or 26 day if in
 cross over group) study period

 Exclusion Criteria:

 -  Has a diagnosis of either psoriasis or eczema

 -  Has a visual diagnosis, by the investigator, of onychomycosis.

 -  Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole-
 (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole,
 econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox
 olamine-(Loprox®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and
 corticosteroids in the preceding 5 days of screening visit (Day 1)

 -  Use of systemic corticosteroids in the preceding 7 days of screening visit (Day 1)

 -  Use of systemic antifungals in the preceding 7 days of screening visit (Day1)
 including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen),
 fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®,
 Pedinol), butoconazole, terconazole, Potassium iodide)

 -  Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)

 -  Has cardiovascular disease, diabetes mellitus, Cushing's Disease, hematological
 malignancy, chronic mucocutaneous candidiasis or atopy

 -  Is pregnant or is a nursing mother

 -  Is a woman of child bearing potential who is not using an adequate form of
 contraception (or abstinence)

 -  Is < 19 years of age

 -  Suffers from a condition, which, in the opinion of the medical investigator, would
 compromise his/her safety