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

Tinea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771342
• Other study ID #: CTP 6
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2008
• Last updated: February 2, 2010
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Nitric Oxide
1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days
• Nitrogen
Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score		Day 12 or Day 26	No
Secondary	Incidence of adverse events		Duration of the study	Yes