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

Phase 2

Completed

Conditions: Tinea Pedis

Interventions: Drug: Water
Drug: Nitric Oxide

Registration Number: NCT02871011

Lead Sponsor: Nitric Solutions Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Water	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Nitric oxide	Nitric Oxide	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Cure: Post Treatment (Day 31)	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.
Incidence of Adverse Events	Duration of the study, 31 days for each participant.	Number of moderate A/E possibly related to treatment
Number of Participants With Therapeutic Failure: Post Treatment (Day 17)	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.
Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.	Day 31	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.
Number of Participants With Complete Cure: Post Treatment (Day 17)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31	Day 1 and 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.