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

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ClinicalTrials.gov Identifier: NCT00771342
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
Nitric BioTherapeutics, Inc

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

Condition or disease Intervention/treatment Phase
Tinea Drug: Nitric Oxide Drug: Nitrogen Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days
Drug: Nitric Oxide
1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days

Placebo Comparator: 2
Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days
Drug: Nitrogen
Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days




Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Duration of the study ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771342


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Nitric BioTherapeutics, Inc

Responsible Party: Chief Technology Officer, Nitric BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00771342     History of Changes
Other Study ID Numbers: CTP 6
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents