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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771342
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : February 3, 2010
Information provided by:
Nitric BioTherapeutics, Inc

October 10, 2008
October 13, 2008
February 3, 2010
December 2008
June 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00771342 on Archive Site
Incidence of adverse events [ Time Frame: Duration of the study ]
Same as current
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Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)
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)
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
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Drug: Nitric Oxide
    1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days
  • Drug: Nitrogen
    Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days
  • Experimental: 1
    1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days
    Intervention: Drug: Nitric Oxide
  • Placebo Comparator: 2
    Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days
    Intervention: Drug: Nitrogen
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Chief Technology Officer, Nitric BioTherapeutics, Inc.
Nitric BioTherapeutics, Inc
Not Provided
Not Provided
Nitric BioTherapeutics, Inc
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP