Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)

Study Overview
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Brief Summary
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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

Official Title
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A Blinded Placebo Controlled Single Cross-over Clinical Trial to Evaluate Fungicidal Activity With Topical Application of 1% Gaseous Nitric Oxide in Subjects With Moderate to Severe Tinea Pedis (Athlete's Foot)

Conditions
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Tinea

Intervention / Treatment
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* Drug: Nitric Oxide
* Drug: Nitrogen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days | Drug: Nitric Oxide<br>* 1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days<br>|
| Placebo Comparator: 2<br>Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days | Drug: Nitrogen<br>* Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score |  | Day 12 or Day 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Duration of the study |