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

NCT ID: NCT02871011

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-13
• Study Completion Date: 2017-02-21

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

Conditions

Tinea Pedis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: DRUG

Delivered as a footbath

Nitric oxide

Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

Delivered as a footbath

Interventions

Nitric Oxide

Delivered as a footbath

Intervention Type: DRUG

Water

Delivered as a footbath

Intervention Type: DRUG

Other Intervention Names

NORS; Placebo

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nitric Solutions Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nitric Solutions Inc.

Locations

Fairmont Medical Clinic

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

SAN-CPT-01

Identifier Type: -

Identifier Source: org_study_id