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

Nitric BioTherapeutics

Status and phase

Completed

Phase 2

Conditions

Tinea

Treatments

Drug: Nitrogen

Drug: Nitric Oxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00771342

CTP 6

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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