Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nitric BioTherapeutics, Inc
• Treatments: Nitric Oxide

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