Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot

Study Overview
=================
Brief 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

Detailed Description
-----------------
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject & Assessor) Primary Purpose: Treatment

Official Title
-----------------
A Blinded Placebo Controlled Clinical Trial To Evaluate Fungicidal Activity With The Topical Application Of Nitric Oxide Releasing Solution (Nors) In Subjects With Moderate To Severe Tinea Pedis (Athlete's Foot)

Conditions
-----------------
Tinea Pedis

Intervention / Treatment
-----------------
* Drug: Nitric Oxide
* Drug: Water


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. | Drug: Water<br>* Delivered as a footbath<br>* Other names: Placebo;|
| Experimental: Nitric oxide<br>Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. | Drug: Nitric Oxide<br>* Delivered as a footbath<br>* Other names: NORS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Cure: Post Treatment (Day 17) | Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score. | Day 17 | 
| Number of Participants With Complete Cure: Post Treatment (Day 31) | Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from >20 to <8) on a scale of 0-64. Improvement is expressed as a lower score. | Day 31 | 
| Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score. | Day 17 | 
| Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score. | Day 31 | 
| Incidence of Adverse Events | Number of moderate A/E possibly related to treatment | Duration of the study, 31 days for each participant. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of >20 (0-64 scale) in the two study groups. Increased improvement is expressed as largest negative change and a lower score. | Day 1 and 31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinea Pedis, Tinea Bronchodilator Agents, Nitric Oxide, Dermatomycoses, Endothelium-Dependent Relaxing Factors, Infectious, Infection, Mycoses, Skin Diseases, Foot Dermatoses, Foot Diseases, Pruritus, Skin Manifestations Signs and Symptoms