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

This study has been completed.
Sponsor:
Information provided by:
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00771342
First received: October 10, 2008
Last updated: February 2, 2010
Last verified: February 2010

October 10, 2008
February 2, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00771342 on ClinicalTrials.gov Archive Site
Incidence of adverse events [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tinea
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00771342
CTP 6
No
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