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

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)

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 Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Water; Drug: Nitric Oxide

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z-16H
      • Fairmont Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.	Drug: Water; Delivered as a footbath; Other Names: Placebo
EXPERIMENTAL: Nitric oxide; Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.	Drug: Nitric Oxide; Delivered as a footbath; 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

Collaborators and Investigators

• Sponsor: Nitric Solutions Inc.
• Investigators: Principal Investigator: Lisa Miller, M.D., Nitric Solutions Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2016
• Primary Completion (ACTUAL): November 14, 2016
• Study Completion (ACTUAL): February 21, 2017

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (ESTIMATE): August 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Infection; Pruritus; Tinea Pedis; Nitric Oxide; Skin Diseases; Endothelium-Dependent Relaxing Factors; Foot Diseases; Infectious; Mycoses; Dermatomycoses; Tinea Bronchodilator Agents; Foot Dermatoses; Skin Manifestations Signs and Symptoms
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: SAN-CPT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED