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
  Purpose

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 Intervention Phase
Tinea
Drug: Nitric Oxide
Drug: Nitrogen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771342

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

No publications provided

Responsible Party: Chief Technology Officer, Nitric BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00771342     History of Changes
Other Study ID Numbers: CTP 6
Study First Received: October 10, 2008
Last Updated: February 2, 2010
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 21, 2014