Skip to main content
OpenTrials
Completed

NCT Number: NCT00771342

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nitric oxide

Drug

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

Nitrogen

Drug

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

Primary outcomes

  1. Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score

    Time frame: Day 12 or Day 26

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Duration of the study

Sponsors and collaborators

Lead sponsor

Nitric BioTherapeutics, Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 13, 2008
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.