Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing
 solution footbath and it's effect on the clinical signs and symptoms associated with Tinea
 Pedis
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:
 Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject &
 Assessor) Primary Purpose: Treatment
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, for study sites located in British Columbia. For other
 locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.

 -  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 31 day study period

 Exclusion Criteria:

 -  Has a diagnosis of either psoriasis or eczema, in or immediately around the area under
 evaluation.

 -  Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the
 opinion of the investigator could compromise the integrity of the study.

 -  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®), tolnaftate, haloprogin), Zeasorb, antibacterials and
 corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately
 around the area under evaluation.

 -  Use of systemic corticosteroids in the preceding 7 days respectively, 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 (GrisPEG®),
 butoconazole, terconazole, Potassium iodide)

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

 -  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, for study sites located in British Columbia. For other locations
 subject is < 18 years of age, unless local laws dictate otherwise.

 -  Suffers from a condition, which, in the opinion of the medical investigator, would
 compromise his/her safety and / or the quality of the data. Such conditions may
 include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological
 malignancy, chronic mucocutaneous candidiasis or atopy