Clinical trial NCT02871011: Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Keywords: Tinea Bronchodilator Agents
Tinea Pedis
Nitric Oxide
Dermatomycoses
Endothelium-Dependent Relaxing Factors
Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations Signs and Symptoms
Lead sponsor: Nitric Solutions Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Participants With Complete Cure: Post Treatment (Day 17)
timeFrame: Day 17
measure: Number of Participants With Complete Cure: Post Treatment (Day 31)
timeFrame: Day 31
measure: Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
timeFrame: Day 17
measure: Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.
timeFrame: Day 31
measure: Incidence of Adverse Events
timeFrame: Duration of the study, 31 days for each participant.
Secondary outcomes:
measure: Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31
timeFrame: Day 1 and 31
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Fairmont Medical Clinic
state: British Columbia
Study officials:
affiliation: Nitric Solutions Inc.
name: Lisa Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: