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

NCT ID: NCT00771342

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-08-31

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

Conditions

Tinea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days

2

Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days

Group Type: PLACEBO_COMPARATOR

Nitrogen

Intervention Type: DRUG

Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days

Interventions

Nitric Oxide

1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days

Intervention Type: DRUG

Nitrogen

Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitric BioTherapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Nitric BioTherapeutics, Inc.

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

CTP 6

Identifier Type: -

Identifier Source: org_study_id