A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00893880
First received: May 4, 2009
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.


Condition Intervention Phase
Tinea Pedis
Drug: 1% gaseous Nitric Oxide blended in Oxygen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis

Resource links provided by NLM:


Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Complete cure (negative KOH and culture and no signs or symptoms), Effective treatment (negative KOH and culture and at most mild erythema or scaling), Negative mycology (negative KOH and culture). [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the clinical and mycological effect of 1% gaseous nitric oxide (gNO) as a treatment for Tinea Pedis in the clinically evaluable population at the Test-of-Cure (TOC) evaluation (4 weeks post-treatment) according to the definitions below: [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
  • Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 2 weeks post treatment outcomes according to definitions below: [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 1 week post treatment outcomes according to definitions below: [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events. [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
(1) 30min treatment
Drug: 1% gaseous Nitric Oxide blended in Oxygen
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.
Experimental: 2
(1) 60min treatment
Drug: 1% gaseous Nitric Oxide blended in Oxygen
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.
Experimental: 3
(2) 30min treatments over two consecutive days.
Drug: 1% gaseous Nitric Oxide blended in Oxygen
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.
Experimental: 4
(2) 60min treatments over two consecutive days.
Drug: 1% gaseous Nitric Oxide blended in Oxygen
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 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 (moderate to severe, indicated by a CSSS ≥ 6) for interdigital or bullous tinea pedis as determined by clinical examination (subjects with moccasin symptoms in addition to above may also be included at the discretion of the investigator).
  • Written informed consent must be obtained from the subject.
  • Must ≥ 18 years of age, unless local laws dictate otherwise.
  • 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 not be pregnant or nursing, and if of childbearing potential, agree to take measures to avoid pregnancy during the study period

Exclusion Criteria:

  • Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
  • Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator would compromise the integrity of the study.
  • 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 14 days of screening visit (Day 1), on or immediately around the area under evaluation.
  • Use of oral or injectable systemic corticosteroids in the preceding 7 or 30 days respectively, of screening visit (Day 1)
  • Use of systemic antifungals in the preceding 30 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)
  • 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 < 18 years of age, unless local laws dictate otherwise.
  • Is immunosuppressed (undergoing chemotherapy, neutropenia (PMNs , < 500/mm3), HIV with CD4+ < 200/mm3.
  • Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy STATISTICS This clinical evaluation is intended to demonstrate
  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: NCT00893880

Locations
Canada, Ontario
Mediprobe Research, Inc
London, Ontario, Canada, N5X 2P1
Saint Kitts and Nevis
Eureka Health Services
Ramsbury Site, Nevis, Saint Kitts and Nevis
Medical Associates
Basseterre, St. Kitts, Saint Kitts and Nevis
Diversified Healthcare Solutions
Basseterre, St. Kitts, Saint Kitts and Nevis
Sponsors and Collaborators
Nitric BioTherapeutics, Inc
  More Information

No publications provided

Responsible Party: Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier: NCT00893880     History of Changes
Other Study ID Numbers: CTP8
Study First Received: May 4, 2009
Last Updated: October 18, 2012
Health Authority: St. Kitts and Nevis: Ministry of Health
Canada: Health Canada

Keywords provided by Nitric BioTherapeutics, Inc:
Tinea Pedis
Athletes Foot
Nitric Oxide

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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014