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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

May 4, 2009
October 18, 2012
June 2009
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00893880 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinea Pedis
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: 1
    (1) 30min treatment
    Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen
  • Experimental: 2
    (1) 60min treatment
    Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen
  • Experimental: 3
    (2) 30min treatments over two consecutive days.
    Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen
  • Experimental: 4
    (2) 60min treatments over two consecutive days.
    Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
May 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Saint Kitts and Nevis
 
NCT00893880
CTP8
No
Nitric BioTherapeutics, Inc
Nitric BioTherapeutics, Inc
Not Provided
Not Provided
Nitric BioTherapeutics, Inc
October 2012

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