Clinical trial NCT00771342: Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)
Official title: A Blinded Placebo Controlled Single Cross-over Clinical Trial to Evaluate Fungicidal Activity With Topical Application of 1% Gaseous Nitric Oxide in Subjects With Moderate to Severe Tinea Pedis (Athlete's Foot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea
Lead sponsor: Nitric BioTherapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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
* 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

Primary outcomes:
measure: Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score
timeFrame: Day 12 or Day 26
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Duration of the study
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References: