Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Nitric Oxide; Water
Intervention description: Delivered as a footbath; Delivered as a footbath
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tinea Bronchodilator Agents; Tinea Pedis; Nitric Oxide; Dermatomycoses; Endothelium-Dependent Relaxing Factors; Infectious; Infection; Mycoses; Skin Diseases; Foot Dermatoses; Foot Diseases; Pruritus; Skin Manifestations Signs and Symptoms

Summary:

      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
    

Eligibility criteria:

        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