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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 (Athl

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 Summary: Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject & Assessor) Primary Purpose: Treatment
Sponsor: Nitric Solutions Inc.

Current Primary Outcome: Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score [ Time Frame: Day 17 or Day 31 ]

The primary efficacy endpoint for this study is to quantify mycological response post NORS treatment applications. Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of adverse events [ Time Frame: Duration of the study, 31 days for each participant. ]

Original Secondary Outcome: Same as current

Information By: Nitric Solutions Inc.

Dates:
Date Received: August 4, 2016
Date Started: August 2016
Date Completion: May 2017
Last Updated: August 12, 2016
Last Verified: August 2016