Tinea
Conditions
Brief summary
The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's effect on the clinical signs and symptoms associated with Tinea Pedis
Interventions
DRUGNitric Oxide
1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days
DRUGNitrogen
Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days
Sponsors
Nitric BioTherapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 * 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 12 day (or 26 day if in cross over group) study period
Exclusion criteria
* Has a diagnosis of either psoriasis or eczema * Has a visual diagnosis, by the investigator, of onychomycosis. * 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®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) * Use of systemic corticosteroids in the preceding 7 days 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 (Gris-PEG®, Pedinol), butoconazole, terconazole, Potassium iodide) * Has used any investigational drug(s) within 30 days preceding screening visit (Day 1) * Has cardiovascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy * 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 * Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score | Day 12 or Day 26 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Duration of the study |
Countries
Canada
Outcome results
None listed